BUSSE HOSPITAL DISPOSABLES

Additional Manufacturer Narrative

AFTER THE INITIAL SUBMISSION OF THE 3500A ON DECEMEBER 22, 2023, BUSSE RECEIVED THE FOLLOWING RESPONSES TO QUESTIONS POSTED TO THE SUBMITTER AS FOLLOWED: 1. HAS ST. CROIX HEALTH SUBMITTED A MEDWATCH REPORT (3500)? A. IF SO, CAN YOU PLEASE SHARE A COPY. A MEDWATCH REPORT HAS NOT BEEN SUBMITTED AT THIS TIME 2. THE DCF SUBMITTED NOTES THAT YOU STILL HAVE STOCK OF LOT#1920272 AVAILABLE, WOULD YOU BE ABLE TO SUBMIT AT LEAST 5EA SAMPLES FROM YOUR STOCK? I ONLY HAVE 1 CURETTE WITH THE LOT # 1920272. I WILL SUBMIT THIS PRODUCT. 3. THE DCF SUBMITTED NOTES "AT THE END OF THE PROCEDURE IT WAS DISCOVERED THAT THE TIP WAS BROKEN" A. WAS THE BROKEN PIECE RETRIEVED? IF SO, WILL THIS BE PART OF THE SAMPLE? THE TIP OF THE CURETTE WAS CRACKED, AND A PIECE OF THE TIP CURLED MAKING A SHARP EDGE. IT IS HARD TO DETERMINE IF THERE IS ANYTHING MISSING FROM THE TIP OF THE CURETTE. 4. WOULD YOU BE ABLE TO LIST OTHER MEDICAL TOOLS USED IN CONJUNCTION OF THE BUSSE CURETTE, INCLUDING THEIR BRAND NAME, AND OTHER IDENTIFIERS SUCH AS MANUFACTURER, LOT AND SETTINGS DURING THE PROCEDURE, IF APPLICABLE? A. DILATION AND CURETTAGE INSTRUMENT SET: 1. 8 PRATT DILATORS (13-41, SKYLAR) 2. SMALL AND MEDIUM HEANEY CURETTE (JARIT- 500-300, SKYLAR- 3) 3. RING FORCEPS ( V. MUELLER GL650) 4. TENACULUM (JARIT 505-200) 5. WEIGHTED SPECULUM ( NO PRODUCT INFO) & GLENNER (V.MUELLER H21 GL360) 6. DISPOSABLE COLLECTION SET, REF 23116 GYRUS ACMI (UNSURE OF LOT USED ON THIS CASE) 7. BERKELY VACUUM CURETTAGE SYSTEM VC2 115VAC, SN 2H1537. SUCTION APPLIED WHEN NEEDLE IN GREEN RANGE (60-70 CM HG) 5. WAS THERE ANY SPECIFIC EVENT OR COMPLICATION DURING THE PROCEDURE THAT LED TO THESE INJURIES? UNKNOWN 6. WHAT MEASURES WERE TAKEN TO ADDRESS THE CRACKED CURETTE AFTER THE PROCEDURE? THE PROVIDER WAS MADE AWARE OF THE CRACKED CURETTE AS SOON AS IT WAS NOTED TO BE BROKEN. PATIENT HAD STAT CT SCAN TO LOOK FOR FOREIGN BODY OR INJURY. SURGICAL SERVICES MANAGER, CNO, VPMA, AND PATIENT WERE NOTIFIED. 7. WERE THERE ANY PRE-EXISTING CONDITIONS OR FACTORS THAT MAY HAVE CONTRIBUTED TO THE COMPLICATIONS EXPERIENCED BY THE PATIENT DURING THE SURGERY? NONE 8. WAS THE PATIENT RECENTLY PREGNANT OR GONE THROUGH MENOPAUSE PRIOR TO THE PROCEDURE? PT WAS RECENTLY PREGNANT. HAVING PROCEDURE FOR MISSED ABORTION. 9. WHAT DIAGNOSTIC TOOLS WERE USED TO CONFIRM THE PERFORATION OF THE UTERUS AND THE EXTENT OF THE INJURIES TO THE FALLOPIAN TUBE AND BOWEL? CT, LAPAROSCOPIC SURGERY (AFTER TRANSFER TO ANOTHER FACILITY) A. PLEASE CLARIFY WHETHER THE DAMAGES TO THE UTERUS AND FALLOPIAN TUBES WERE NOTED AFTER THE SURGERY, OR WERE THEY KNOW PRIOR TO THE SURGERY. INJURIES WERE NOTED AFTER 10. HOW WAS THE DECISION MADE TO TRANSFER THE PATIENT TO A HIGHER LEVEL OF CARE, AND WHAT SPECIFIC INTERVENTIONS WERE INITIATED TO STABILIZE THE PATIENT'S CONDITION? DECREASE IN HGB, CONCERN FOR POSSIBILITY OF INJURIES NOT SEEN ON CT 11. IN THE SUBSEQUENT SURGERY WHERE ONE FALLOPIAN TUBE WAS REMOVED, WHAT WAS THE RATIONALE BEHIND THIS DECISION, AND HOW WAS THE PROCEDURE CARRIED OUT? THE FALLOPIAN TUBE WAS FOUND TO BE NECROTIC. THE SURGERY WAS DONE LAPAROSCOPICALLY. 12. WHAT POST-OPERATIVE CARE AND MONITORING MEASURES WERE IMPLEMENTED TO ADDRESS THE SIGNIFICANT BLEEDING AND THE DROP IN HEMOGLOBIN LEVELS? MONITORING VITAL SIGNS, LABS (SERIAL HGB). ST. CROIX HEALTH WAS NOT AWARE INITIALLY OF "SIGNIFICANT" BLEEDING 13. HAVE THERE BEEN ANY DISCUSSIONS OR PLANS FOR LONG-TERM FOLLOW-UP CARE, AND WHAT POTENTIAL IMPLICATIONS OR COMPLICATIONS MIGHT BE EXPECTED IN THE PATIENT'S RECOVERY PROCESS? A. WHAT IS THE CURRENT STATUS OF THE PATIENT? UNSURE OF LONG-TERM FOLLOW-UP PLAN. PT DID HAVE ILEUS WHILE IN HOSPITAL. PATIENT HAS BEEN DISCHARGED. DURING THE INVESTIGATION, BUSSE CONDUCTED THE FOLLOWING INSPECTIONS: 1. INSPECTION OF STOCKED PRODUCT: SAMPLES WERE TAKEN FROM BOTH THE PACKAGED (ITEM #284) AND BULK FORM (ITEM #2480C) OF THE PRODUCT IN STOCK. THE CURETTES WERE TESTED ACCORDING TO ESTABLISHED QUALITY ASSURANCE SPECIFICATIONS, AND THE RESULTS WERE DEEMED ACCEPTABLE. IT'S IMPORTANT TO NOTE THAT THE PRODUCT IN STOCK IS NO LONGER PURCHASED FROM THE SAME VENDOR AS IN THE REPORTED LOT. NEVERTHELESS, THIS CONFIRMED THE CONFORMITY OF THE PRODUCT IN STOCK, ALLOWING US TO CONFIDENTLY CONTINUE ITS USE. 2. INSPECTION OF PRODUCT FROM THE SAME VENDOR AS THE REPORTED PRODUCT: WHILE THE SAME CURETTE VENDOR STOCK REPORTED IN THE CATALOG WAS NO LONGER AVAILABLE, OTHER STOCK FROM THE SAME VENDOR CONTAINING THE CURETTE IN A DIFFERENT FORM (CAT#138, 12MM STRAIGHT CURETTE) WAS INSPECTED. THE PRODUCT UNDERWENT INSPECTION AND TESTING IN ACCORDANCE WITH QUALITY ASSURANCE REQUIREMENTS, MEETING ALL STANDARDS. THE REPORTED ISSUE COULD NOT BE REPLICATED. 3. INSPECTIONS OF USER-SUBMITTED SAMPLES: TWO SAMPLES WERE SUBMITTED FOR REVIEW AND RECEIVED AT BUSSE ON 01/02/2024. ONE SAMPLE HAD BEEN USED AND EXHIBITED A MISSING PART AT THE TIP, WHILE THE OTHER WAS AN UNUSED PACKAGED SAMPLE FROM THE SAME LOT. USED SAMPLE: THIS SAMPLE WAS SENT FOR STERILIZATION BEFORE OBSERVATION. IT WAS NOTED THAT THE TIP OF THE CURETTE HAD A SMALL PIECE MISSING. HOWEVER, DUE TO THE SAMPLE'S STATE AND CONTAMINATION WITH BLOOD, FURTHER TESTING COULD NOT BE PERFORMED. UNUSED SAMPLE: THE SAMPLE UNDERWENT TESTING FOLLOWING THE SAME QUALITY ASSURANCE SPECIFICATIONS AND PASSED ALL TESTING. THE REPORTED ISSUE COULD NOT BE REPLICATED. ALL INSPECTION REPORTS ARE AVAILABLE UPON REQUEST. CONCLUSION: AT THE TIME OF THE INITIAL 3500A SUBMISSION, BUSSE HAD IDENTIFIED TWO POTENTIAL ROOT CAUSES. HOWEVER, DUE TO THE INABILITY TO REPLICATE THE REPORT'S FINDINGS IN MULTIPLE INSPECTIONS, A CONCLUSIVE IDENTIFICATION OF THE ROOT CAUSE REMAINS ELUSIVE. WE BELIEVE THE TWO INITIAL CONCLUSIONS MAY STILL BE RELEVANT, BUT WITH THE CURRENT INFORMATION, CERTAINTY IS LACKING. IT IS UNCLEAR WHETHER ONE OF THE CAUSES APPLIES, OR IF IT COULD BE A COMBINATION OF BOTH. 1. INAPPROPRIATE USE: A. BUSSE ASSERTS THAT THE MATERIAL PROPERTIES USED TO MANUFACTURE THIS PRODUCT ARE KNOWN FOR EXCEPTIONAL SHATTER RESISTANCE AND DURABILITY, CONFIRMED THROUGH TESTING ON ALL SAMPLES. SINCE NO SAMPLE SHATTERED, CRACKED, OR BROKE UNDER PRESSURE, WE MAINTAIN THAT THIS INCIDENT IS ISOLATED, WITH NO IDENTIFIABLE TRENDS INDICATING ISSUES WITH THE PRODUCT'S FORM, FIT, FUNCTION, OR OVERALL DESIGN. DESPITE THE USER'S APPARENT KNOWLEDGE IN RESPONSES, WE CANNOT RULE OUT THE POSSIBILITY OF INAPPROPRIATE USE BASED ON THE DESCRIBED CIRCUMSTANCES. 2. HANDLING DURING TRANSIT: A. MANUFACTURING YEAR: AS NOTED IN THE INITIAL SUBMISSION, THE LOT IN QUESTION WAS PRODUCED IN 2019. CONSIDERING THE UNCERTAINTY REGARDING THE PRODUCT'S HANDLING SINCE PRODUCTION, THE POSSIBILITY OF DAMAGE DURING TRANSIT CANNOT BE DISMISSED AFTER INVESTIGATION AND INSPECTION RESULTS. B. INVISIBLE DAMAGE: AS MENTIONED IN THE INITIAL SUBMISSION AND CONFIRMED THROUGH INVESTIGATION AND INSPECTION RESULTS, IT CANNOT BE RULED OUT THAT CONCEALED DAMAGES OCCURRED FROM PRODUCTION TO THE DATE OF USE DURING TRANSIT OR STORAGE. THE PRODUCT MIGHT HAVE HAD A PRE-EXISTING CONDITION, SUCH AS A FRACTURE, WHICH, WHEN COMBINED WITH SUBSEQUENT USE, LED TO THE EVENTUAL BREAKAGE OF THE PART. OVERALL, THE CONCLUSIVE IDENTIFICATION OF THE ROOT CAUSE IS CHALLENGING, AND UNCERTAINTIES REMAIN REGARDING THE APPLICABILITY OF THE TWO POTENTIAL CONCLUSIONS. DESPITE THE COMPLEXITIES OUTLINED ABOVE, A FURTHER INVESTIGATION IS NOT WARRANTED. BUSSE, RELYING ON HISTORICAL DATA AND THE LACK OF IDENTIFIED TRENDS IN INSPECTIONS THROUGHOUT THE INVESTIGATION, DOES NOT INDICATE ANY SYSTEMIC ISSUES WITH OUR PRODUCT. THE COMPREHENSIVE TESTING AND EXAMINATION RESULTS PROVIDE NO EVIDENCE OF PROBLEMS RELATED TO THE PRODUCT'S DESIGN, FORM, FIT, OR FUNCTION. IT IS NOTEWORTHY THAT THE COMPLAINANT MENTIONED THE ABSENCE OF A MEDWATCH FILING WITH THE FDA FROM THE FACILITY. IN LIGHT OF THIS, WE RECOMMEND THAT THE FACILITY SUBMIT A MEDWATCH REPORT TO THE FDA FOR AN INDEPENDENT INVESTIGATION. IMPORTANTLY, IT SHOULD BE EMPHASIZED THAT THE REPORTED ISSUE DOES NOT APPEAR TO STEM FROM A FAILURE OF THE MEDICAL DEVICE IN QUESTION, AS INDICATED BY THE INSPECTION RESULTS AND HISTORICAL DATA.

Description of Event or Problem

ON (B)(6) 2023, (B)(6) HOSPITAL DISPOSABLES RECEIVED AN EMAIL REPORT FROM (B)(6). THE REPORT INDICATED THAT A PRODUCT, SPECIFICALLY LOT#1920275 FOR CATALOG 284 (BUSSE'S 12MM CURETTE), HAD BROKEN DURING SURGERY ON (B)(6) 2023. AFTER OBTAINING ADDITIONAL INFORMATION FROM (B)(6) ABOUT THE INCIDENT, ON (B)(6) 2023, BUSSE HOSPITAL DISPOSABLES FORMALLY SUBMITTED A 3500A. THIS SUBMISSION IS INTENDED TO PROVIDE AN UPDATE TO OUR ORIGINAL REPORT, INCORPORATING OBSERVATIONS FROM OUR INVESTIGATION AND INSPECTIONS CONDUCTED, AND TO CONCLUDE THE REPORT.

Description of Event or Problem

ON DECEMBER 14, 2023, (B)(6) HOSPITAL DISPOSABLES RECEIVED AN EMAIL REPORT FROM (B)(6), STATING THAT A PRODUCT BROKE DURING SURGERY ON (B)(6), 2023. THE SPECIFIC PRODUCT IN QUESTION WAS LOT#1920275 FOR CATALOG 284, WHICH IS BUSSE'S 12MM CURETTE. UPON RECEIVING THE REPORT, BUSSE PROMPTLY REVIEWED IT AND ASSIGNED A COMPLAINT NUMBER, COMPLAINT# (B)(4), TO INITIATE AN INVESTIGATION. IMMEDIATE STOCK INSPECTION REVEALED THAT THE CURRENT STOCK OF THE PRODUCT WAS IN CONFORMITY WITH THE STANDARDS. ADDITIONALLY, FOR OUR INITIAL INVESTIGATION, WE THOROUGHLY EXAMINED OUR QUALITY SYSTEM TO DETECT ANY PATTERNS OR TRENDS ASSOCIATED WITH THE SPECIFIC PRODUCT OR PRODUCT FAMILY IN QUESTION THAT COULD HELP US PINPOINT THE LIKELY CAUSE OF THE INCIDENT. OUR INVESTIGATION REVEALED NO COMPLAINTS, ISSUES WITH THE MATERIAL, OR SUBSTANTIAL DATA INDICATING ANY PROBLEMS WITH THE PRODUCT. THIS INCLUDES THE MATERIAL USED, KNOWN TO BE TOUGH ENOUGH TO RESIST ACCIDENTAL BREAKAGE AND WHICH HAD BEEN IN USE FOR SEVERAL YEARS WITHOUT ANY REPORTED PROBLEMS. SIMULTANEOUSLY, BUSSE CONTACTED (B)(6), , ACKNOWLEDGING THE REPORT, OPENING A COMPLAINT FOR INVESTIGATION, AND SEEKING MORE DETAILS ABOUT THE INCIDENT. DESPITE AN INITIAL LACK OF RESPONSE, A FOLLOW-UP WAS CONDUCTED ON (B)(6), 2023. IN RESPONSE, (B)(6), CLARIFIED THAT THE PROCEDURE IN QUESTION WAS A DILATION AND CURETTAGE WITH VACUUM CURETTAGE. AND MORE SPECIFICALLY EXPLAINED "IT IS POSSIBLE THE COMPLICATIONS PATIENT HAS WERE DUE TO A CRACKED VACUUM CURETTE. THE PATIENT DID HAVE A PERFORATION OF THE UTERUS AND INJURY TO FALLOPIAN TUBE AND BOWEL. IT IS UNKNOWN HOW THE CURETTE CAME TO BE CRACKED. IT WAS NOT NOTED TO BE CRACKED AT THE START OF THE CASE AND IT WAS CRACKED AT THE END OF THE CASE. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE AND HAD A RETURN TO OR WHERE ONE FALLOPIAN TUBE WAS REMOVED. NO BOWEL REPAIR WAS NEEDED AT THIS TIME. SHE HAD SIGNIFICANT BLEEDING WITH A DROP IN HEMOGLOBIN FROM 11 TO 8.8." REFER TO THE EMAIL DATED 12/20 ATTACHED. UPON RECEIVING THIS DETAILED INFORMATION, BUSSE HOSPITAL DISPOSABLES DETERMINED THAT THIS INCIDENT IS A REPORTABLE EVENT. FURTHER INQUIRIES WERE MADE TO (B)(6), FOR ADDITIONAL INFORMATION ON THE INCIDENT AND THE PATIENT. SAMPLE, WHICH HAS BEEN REPORTED TO BE AVAILABLE WAS REQUESTED, AND CLARIFICATION WAS SOUGHT REGARDING THE INTERCHANGEABLE USE OF THE TERMS "BROKEN" ON 12/14 AND "CRACKED AND CURLED" ON 12/20 IN THE COMMUNICATIONS. AT PRESENT, GIVEN THE AVAILABLE INFORMATION AND PENDING THE ARRIVAL OF THE SAMPLE, (B)(6) HOSPITAL DISPOSABLES IS CONSIDERING VARIOUS HYPOTHESES REGARDING THE OBSERVED ISSUE: 1. INAPPROPRIATE USE: A. MATERIAL PROPERTIES: THE MATERIAL IS RENOWNED FOR ITS EXCEPTIONAL SHATTER RESISTANCE AND DURABILITY AGAINST ACCIDENTAL BREAKAGE. IN THE ABSENCE OF SIMILAR INCIDENTS OR IDENTIFIABLE TRENDS, IT IS REASONABLE TO SPECULATE THAT USER ERROR MIGHT BE THE CAUSE. 2. HANDLING DURING TRANSIT: A. MANUFACTURING YEAR: THE LOT IN QUESTION WAS PRODUCED IN 2019, AND CONSIDERING THE UNCERTAINTY REGARDING THE PRODUCT'S JOURNEY AND HANDLING SINCE ITS PRODUCTION, IT RAISES THE POSSIBILITY OF DAMAGE DURING TRANSIT. B. INVISIBLE DAMAGE: THE NATURE OF THE MATERIAL AND COLOR OF THE PART MAY HAVE CONCEALED ANY DAMAGE INCURRED DURING SHIPPING OR STORAGE. THIS CONCEALED DAMAGE COULD HAVE BEEN A PRE-EXISTING CONDITION, SUCH AS A FRACTURE, WHICH, WHEN COUPLED WITH SUBSEQUENT USE, LED TO THE EVENTUAL BREAKAGE OF THE PART. AS WE AWAIT RESPONSES TO FOLLOW-UP INQUIRIES AND THE SUBMISSION OF THE SAMPLE, BUSSE REMAINS COMMITTED TO THOROUGHLY EXAMINING THESE POTENTIAL SCENARIOS. THIS COMPREHENSIVE REVIEW WILL AID IN THE DETERMINATION OF THE ROOT CAUSE AND APPROPRIATE COURSE OF ACTION.