CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

Description of Event or Problem

DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE METAL "JAW" [CUP] PART WITH THE SERRATED EDGES FELL APART. 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

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 REPORT COULD NOT BE CONFIRMED. 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. PRIOR TO DISTRIBUTION, ALL CAPTURA PRO BIOPSY FORCEPS WITH 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 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.

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC 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 IN A 3 COIL POSITION. DURING A VISUAL EXAMINATION, IT COULD BE SEEN THAT THE FORCEPS HOUSING HAD SEPARATED FROM THE COIL CATHETER. THE FORCEPS WOULD NOT OPEN AND CLOSE WITH HANDLE MANIPULATION. WHEN THE HANDLE WAS MANIPULATED, THE FORCEPS CUPS AND HOUSING MOVED AWAY FROM THE CATHETER BUT REMAINED ATTACHED TO THE DRIVE WIRE. UNDER MAGNIFICATION, THE FORCEPS HOUSING AND COIL SPRING WERE EXAMINED FOR WELD MARKS. THE WELD MARK ON THE PROXIMAL END OF ONE SIDE OF THE HOUSING APPEARS TO BE MORE PRONOUNCED THAN THE OTHER SIDE. ADDITIONALLY, THERE IS ONE INDENTION ON THE DISTAL END OF THE EXPOSED COILED CATHETER AS OPPOSED TO TWO. A FUNCTION TEST WAS NOT POSSIBLE, DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION AND THE FOLLOWING WAS PROVIDED, DEVICE WAS RECEIVED IN A 3-LOOP COIL POSITION. DEVICE HANDLE WAS OBSERVED TO HAVE A GOUGE ON THE SPOOL; THIS IS A COSMETIC ANOMALY UNRELATED TO THE REPORTED COMPLAINT. THE TWO FORK HALVES WERE NOT ATTACHED TO THE COIL CABLE, BUT THE CUPS WERE STILL ATTACHED TO THE LINK WIRES AND THE PIVOT PIN WAS PROPERLY SWAGED, KEEPING THE JAW ASSEMBLY INTACT. SWAGED REGION OF CABLE APPEARED TO BE SLIGHTLY SKEWED. BOTH OF THE INDIVIDUAL FORK HALVES APPEARED TO HAVE WELD SPOTS IN THE PROPER LOCATION. MARKS ON THE INSIDE OF THE FORK COMPONENTS AND ON COIL CABLE WERE OBSERVED, INDICATING WELD PENETRATION. MANIPULATION OF THE HANDLE SHOWED THAT THE LINK WIRES COULD BE MOVED FREELY WITHIN THE COIL CABLE WITH NO RESISTANCE FELT. DEVICE COULD NOT BE FULLY EVALUATED FOR FUNCTIONALITY, DUE TO THE DETACHED FORK HALVES. THE REPORTED COMPLAINT FOR DETACHED TIP WAS ABLE TO BE CONFIRMED. ALL COMPONENTS OF THE INNER JAW ASSEMBLY WERE PRESENT AND INTACT, BUT THE FORK HALVES HAD SEPARATED FROM THE COIL CABLE. WELDS WERE CLEARLY VISIBLE ON FORK COMPONENTS, AND WERE IN THE APPROPRIATE LOCATION ON EACH. SWAGED DIAMETER OF CABLE MEASURED WITH CALIBRATED CALIPERS, AND FOUND WITHIN THE ACCEPTABLE RANGE PER THE DRAWING. ALL DEVICES ARE CHECKED AT FQC TO VERIFY ATTACHMENT OF FORK TO CABLE AS DIRECTED ON CHECKLIST FORM, NO RELEVANT DEFECTS WERE NOTED IN THE REVIEW OF THE DEVICE HISTORY RECORDS. IT WAS UNABLE TO BE DETERMINED WHY THE FORK DETACHED FROM THE COIL CABLE. THE DEVICE HISTORY RECORD FOR WAS REVIEWED. THERE WERE NO RELEVANT DEFECTS NOTED IN THE FQC CHECKLIST. 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: THE SUPPLIER PROVIDED THE FOLLOWING, "THE COMPLAINT WAS CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED. THE USER'S COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT REVEAL ANY RELEVANT DEFECTS. A VISUAL EVALUATION OF THE DEVICE REVEALED THE TWO FORK HALVES HAD SEPARATED FROM THE COIL. ALL REMAINING COMPONENTS OF THE INNER JAW ASSEMBLY WERE PRESENT AND INTACT. A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. ROOT CAUSE COULD NOT BE DETERMINED. ALL DEVICES RECEIVE A 100% INSPECTION PRIOR TO RELEASE AND SHIPMENT TO ENSURE THE DEVICE IS WORKING PROPERLY." PRIOR TO DISTRIBUTION, ALL CAPTURA PRO¿ BIOPSY FORCEPS WITH 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 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 UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE METAL "JAW" [CUP] PART WITH THE SERRATED EDGES FELL APART. THE RETURNED DEVICE EXHIBITED MISALIGNED CUPS. 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.