CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE

Description of Event or Problem

DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE IT WAS REPORTED THAT A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE CAPTURA PRO BIOPSY FORCEPS WITHOUT SPIKE, G47699, WERE USED. WHILE TAKING A BIOPSY, THE JAW DETACHED FROM THE DEVICE. THE JAW PIECE WAS RETRIEVED SUCCESSFULLY FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

Additional Manufacturer Narrative

CONTINUED: SECTION G: 510K: K200972 INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A BIOHAZARD BAG WITH AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH NO SIGN OF DAMAGE TO THE HANDLE OR CATHETER, HOWEVER ONE SIDE OF THE CUPS AND LINK WIRE WAS NOT ATTACHED OR RETURNED. WHEN THE HANDLE WAS MANIPULATED, THE REMAINING CUP OPENED AND CLOSED AS EXPECTED. UNDER MAGNIFICATION IT WAS NOTED THAT ONE FORCEPS CUP AND LINK WIRE WAS MISSING. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION AND THE FOLLOWING WAS PROVIDED, "VISUAL EVALUATION OF THE RETURNED DEVICE CONFIRMED THE COMPLAINT OF ONE DETACHED CUP. NO DAMAGE WAS VISIBLE TO THE REST OF THE JAW ASSEMBLY, COIL CABLE, COATING, OR HANDLE COMPONENTS OF THE DEVICE. DUE TO THE CONDITION OF THE RETURNED DEVICE, FULL FUNCTIONALITY OF THE DEVICE COULD NOT BE PERFORMED; HOWEVER, IT WAS CONFIRMED THAT THE DEVICE COULD BE ACTUATED IN THE U-BEND AND 3-COIL POSITIONS. THE COMPLAINT OF DETACHED CUP WAS CONFIRMED WITH VISUAL EVALUATION. THE DEVICE COMPONENTS WERE DISASSEMBLED AND REMOVED FROM THE DEVICE. DEVICE COMPONENTS SHOWED NO INTERNAL SIGNS OF DAMAGE. WHEN THE TIP ASSEMBLY WAS DISASSEMBLED, THE PIVOT PIN WAS MISSING SWAGE. THE PT'S AND INSPECTION RECORDS OF THE TIP ASSEMBLY WAS REVIEWED AND NO DEFECTS WERE NOTED ON THE INSPECTION RECORD OF TIP ASSEMBLY. REVIEWING THE ACTUAL PROCESS, THE FORCE USED BY THE OPERATOR ON THE MANUAL PRESS WAS NOT A FACTOR, AS THE HEIGHT OF THE PRESS IS FIXED; THUS, THE AMOUNT OF PRESSURE APPLIED WAS NOT A FACTOR. IF THE OPERATOR DID NOT STACK THE PARTS CORRECTLY, STACKED THE LAST PIECE AT AN ANGLE, OR DID NOT FAN THEM OUT COMPLETELY PER PROCEDURE, THE SWAGE DIAMETER OF THE TIP ASSEMBLY COULD BE AFFECTED. (MAN, CONTRIBUTING FACTOR). THE VISUAL INSPECTION STANDARD WAS REVIEWED, AND THE PHOTOS WERE INADEQUATE. THE PROCESS TRAVELER (PT) DID NOT INCLUDE A SIGNOFF FOR VISUAL INSPECTION OF THE SWAGE OR A METHOD FOR INSPECTION. WORK STATION INSTRUCTION DID NOT REQUIRE INSPECTION UNDER MAGNIFICATION (METHOD, ROOT CAUSE). INSPECTION RECORD WAS REVIEWED, AND IT WAS DETERMINED TO ADD ADDITIONAL SAMPLES AT THE BEGINNING AND END OF THE PRODUCTION RUN, AS WELL AS IN THE AFFECTED PRODUCTION DOCUMENTS. THE DOCUMENTS WERE UPDATED AND AFFECTED OPERATORS WERE TRAINED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO RELEVANT DEFECTS NOTED IN THE MANUFACTURING/FQC CHECKLISTS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE SUPPLIER PROVIDED THE FOLLOWING, "ROOT CAUSE WAS DETERMINED TO BE METHOD, THE PIVOT PIN WAS MISSING SWAGE. THE ASSOCIATED DOCUMENTS WERE RECENTLY REVISED AND AFFECTED OPERATORS WERE TRAINED TO UPDATED DOCUMENTS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALIES. THE VISUAL EVALUATION OF THE DEVICE CONFIRMED THE CUSTOMER'S COMPLAINT OF THE "CUP/JAW FELL OFF." FURTHER EVALUATION DETERMINED THE CAUSE OF THE FAILURE WAS DUE TO THE PIVOT PIN MISSING SWAGE, ROOT CAUSE, METHOD. RELEVANT DOCUMENTS HAVE BEEN REVISED AND OPERATORS TRAINED ON THE UPDATED DOCUMENTS." PRIOR TO DISTRIBUTION, ALL CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

Description of Event or Problem

DURING AN ENDOSCOPIC PROCEDURE FOR RANDOM TISSUE BIOPSY IN THE STOMACH, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE IT WAS REPORTED THAT WHILE TAKING A BIOPSY, THE JAW DETACHED FROM THE DEVICE. THE JAW PIECE WAS RETRIEVED SUCCESSFULLY FROM THE PATIENT USING A RETRIEVAL NET. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.