CAPTURA BIOPSY FORCEPS WITHOUT SPIKE

Additional Manufacturer Narrative

INITIAL REPORTER SECTION: OCCUPATION - UNKNOWN. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE CUSTOMER PROVIDED THREE IMAGES OF THE REPORTED DEVICE. THE FIRST IMAGE SHOWS THE DEVICE IN THE CLOSED POSITION. THE CUPS ARE BOTH TILTED TO ONE SIDE, AND ONE OF THE LINK WIRES IS SLIGHTLY STICKING OUT THE BACK. THE REST OF THE DEVICE APPEARS COILED IN LOOPS. THE SECOND PICTURE SHOWS THE CUPS CLOSED BUT TILTED AT A 90 DEGREE ANGLE WITH RESPECT TO THE CATHETER. THE LINK WIRES ARE STICKING OUT THE BACK, THEY APPEAR DAMAGED AND TANGLED TOGETHER. THE THIRD PHOTO SHOWS THE DEVICE IN A SIMILAR POSITION AS THE FIRST PHOTO, BUT THERE IS A GAP IN-BETWEEN THE CUPS THAT IS VISIBLE. THE REPORT IS CONFIRMED BASED SOLELY ON THE PHOTOS PROVIDED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE CUSTOMER PHOTOS SHOW LINK WIRE DAMAGE, IF THE LINK WIRES BECOME DAMAGED AND TANGLED TOGETHER, THE DEVICE WILL NOT OPEN AND CLOSE AS INTENDED. THE INSTRUCTIONS FOR USE PRODUCT INSPECTION: "BEGINNING AT THE HANDLE AND MOVING TOWARD THE CUPS, UNCOIL THE FORCEPS MAKING SURE NOT TO STRETCH THE CABLE. OPEN AND CLOSE THE CUPS TO VERIFY SMOOTH HANDLE OPERATION AND APPROPRIATE CUP ACTION. NOTE: EXERCISING THE HANDLE WHILE THE FORCEPS IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE FORCEPS." PRIOR TO DISTRIBUTION, ALL CAPTURA BIOPSY FORCEPS WITHOUT SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE PHYSICIAN PERFORMED THE FIRST BIOPSY SUCCESSFULLY. BUT, WHEN HE TRIED TO PERFORM A NEW COLLECTION THE FORCEPS DAMAGED ITS OPENING MECHANISM NEXT TO THE FORCEPS SHELL, PREVENTING ITS USE FOR COLLECTION A NEW FRAGMENT [SIC]. THREE IMAGES WERE PROVIDED FOR INVESTIGATION. THE IMAGES SHOWED A GAP IN-BETWEEN THE CUPS [SUBJECT OF REPORT]. 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

INITIAL REPORTER SECTION: OCCUPATION- UNKNOWN. CORRECTION- THE SUMMARY REPORT DESIGNATION IS INCORRECT, THE REPORT IS NOT A SUMMARY REPORT. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE CUSTOMER PROVIDED THREE IMAGES OF THE REPORTED DEVICE. THE FIRST IMAGE SHOWS THE DEVICE IN THE CLOSED POSITION. THE CUPS ARE BOTH TILTED TO ONE SIDE, AND ONE OF THE LINK WIRES IS SLIGHTLY STICKING OUT THE BACK. THE REST OF THE DEVICE APPEARS COILED IN LOOPS. THE SECOND PICTURE SHOWS THE CUPS CLOSED BUT TILTED AT A 90 DEGREE ANGLE WITH RESPECT TO THE CATHETER. THE LINK WIRES ARE STICKING OUT THE BACK, THEY APPEAR DAMAGED AND TANGLED TOGETHER. THE THIRD PHOTO SHOWS THE DEVICE IN A SIMILAR POSITION AS THE FIRST PHOTO, BUT THERE IS A GAP IN-BETWEEN THE CUPS THAT IS VISIBLE. THE REPORT IS CONFIRMED BASED SOLELY ON THE PHOTOS PROVIDED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE CUSTOMER PHOTOS SHOW LINK WIRE DAMAGE, IF THE LINK WIRES BECOME DAMAGED AND TANGLED TOGETHER, THE DEVICE WILL NOT OPEN AND CLOSE AS INTENDED. THE INSTRUCTIONS FOR USE PRODUCT INSPECTION: "BEGINNING AT THE HANDLE AND MOVING TOWARD THE CUPS, UNCOIL THE FORCEPS MAKING SURE NOT TO STRETCH THE CABLE. OPEN AND CLOSE THE CUPS TO VERIFY SMOOTH HANDLE OPERATION AND APPROPRIATE CUP ACTION. NOTE: EXERCISING THE HANDLE WHILE THE FORCEPS IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE FORCEPS." PRIOR TO DISTRIBUTION, ALL CAPTURA BIOPSY FORCEPS WITHOUT SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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.

Additional Manufacturer Narrative

RATIONALE FOR THE DECISION TO CEASE REPORTING TO THE FDA FOR MISALIGNMENT OF THE FORCEPS CUPS FOR PRODUCT CODES EOQ, PTS, AND KGE: COOK ENDOSCOPY FORCEPS ARE INTENDED FOR OBTAINING BIOPSY SAMPLES IN THE BRONCHI AND LUNGS, TO OBTAIN ENDOSCOPIC MUCOSAL TISSUE BIOPSIES AND/OR FOR FOREIGN BODY RETRIEVAL, AND ARE USED ENDOSCOPICALLY IN CONJUNCTION W/MONOPOLAR ELECTROSURGICAL CURRENT TO OBTAIN GASTROINTESTINAL MUCOSAL TISSUE BIOPSIES AND FOR REMOVAL OF SESSILE POLYPS. THEY ARE COLD OR HOT (ELECTROSURGICAL) FORCEPS THAT BIOPSY, REMOVE SESSILE POLYPS OR RETRIEVE FOREIGN BODIES. THE FORCEPS FUNCTION BY CLOSING FORMED METAL CUPS AROUND TISSUE TO EXCISE OR RETRIEVE FOREIGN OBJECTS. IF THE FORCEPS CUPS DO NOT ALIGN CORRECTLY OR COMPLETELY PER SPECIFICATION OR HAVE A GAP BETWEEN EDGE WHILE IN CLOSED POSITION, THEY ARE MISALIGNED. A SERIOUS INJURY RELATED TO MISALIGNMENT OF THE FORCEPS CUPS HAS NOT OCCURRED SINCE THE PRECEDENT EVENT IN 2011. THE PROBABILITY OF ANOTHER SERIOUS INJURY RELATING TO MISALIGNMENT OF THE FORCEPS CUPS IS NEGLIGIBLE. SINCE THE PRECEDENT EVENT, THIS MALFUNCTION HAS NOT CAUSED OR CONTRIBUTED TO ANY SUBSEQUENT SERIOUS INJURIES OUT OF EIGHTY-FOUR (84) TOTAL EVENTS. THUS, THERE IS A REMOTE OCCURRENCE RATE OF 0.00% FOR A SERIOUS INJURY SINCE THE PRECEDENT EVENT WAS REPORTED. THEREFORE, IT IS CONCLUDED THAT THE LIKELIHOOD THAT MISALIGNMENT OF THE FORCEPS CUPS TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IS REMOTE. IN CONCLUSION, MDR REPORTING OF THIS MALFUNCTION HAS CEASED. RESUMPTION OF MDR REPORTING OF THIS MALFUNCTION WILL BE TRIGGERED IF THERE IS RECURRENCE OF A SERIOUS INJURY OR DEATH FOR THE SAME MALFUNCTION.