CAPTURA BIOPSY FORCEPS WITHOUT SPIKE

Additional Manufacturer Narrative

CONTINUED: E1 COUNTRY: COLOMBIA POSTAL CODE: (B)(6). THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

Description of Event or Problem

DURING A GASTRIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GASTRIC BIOPSY PROCEDURE AND THE FORCEPS WOULD NOT OPEN OR CLOSE AFTER BEING INSERTED INTO THE ENDOSCOPE. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE PRELIMINARY QE EVALUATION OF THE DEVICE SHOWS THE FORCEPS HEAD LINK WIRE IS BROKEN. 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: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A PLASTIC BAG. NO LOT NUMBER WAS RETURNED WITH THE DEVICE. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED IN A COILED POSITION AND ONE LINK WIRE IS BROKEN. WHEN THE HANDLE IS MANIPULATED, THERE IS DIFFICULTY IN CLOSING THE FORCEPS CUPS. UPON FURTHER INSPECTION UNDER VISUAL MAGNIFICATION, IT COULD BE SEEN THAT ONE OF THE LINK WIRES IS BROKEN. 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, "VISUAL EVALUATION OF THE RETURNED DEVICE CONFIRMS THAT THE LINK WIRE WAS BROKEN POST PROCEDURE. NO OTHER AESTHETIC DEFECTS WERE OBSERVED. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT THAT THE FORCEPS WOULD NOT OPEN OR CLOSE CANNOT BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. ADDITIONALLY, THERE WAS NO FUNCTIONALITY TEST BECAUSE OF THE BROKEN LINK WIRE. UPON DISSECTION OF THE DEVICE THE SOLDER JOINT WAS OBSERVED TO HAVE FLARING. THIS CAUSED THE LINK WIRES TO BECOME CAUGHT ON THE COIL CABLE RESULTING IN THE FAILURE TO CLOSE THE FORCEPS COMPLETELY. EXCESSIVE FORCE WAS USED IN AN ATTEMPT TO CLOSE THE FORCEPS WHICH LED TO A FAILURE MODE IN THE LINK WIRE. ROOT CAUSE OF THE FAILURE WAS DETERMINED TO BE THE SOLDERING JOINT AT THE LINK WIRES AND DRIVE WIRE. FURTHER TRAINING HAS BEEN INITIATED. THE PROCESS TRAVELERS AND INSPECTION RECORDS OF THE TIP ASSEMBLY WERE REVIEWED AND SHOWED NO DEFECTS IN THE ACTUATIONS. ALL TESTING FIXTURES AND GAUGES ARE WITHIN THE CALIBRATION DATE AT THE TIME OF MANUFACTURING AND FQC. CAPTURA DEVICES ARE 100% INSPECTED FOR NORMAL CLOSING FORCE. FQC SHOWS THAT THERE WERE THREE DEVICES THAT WERE REJECTED AND DOCUMENTED ON THE FORM, DEFECTS RECORD. THE DEVICE HISTORY RECORDS FOR WERE REVIEWED AND WERE MANUFACTURED APRIL 2024. THERE WERE RELEVANT DEFECTS NOTED IN THE MANUFACTURING/FQC CHECKLISTS FOR FAILED PULL TEST. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. THE SAME MANUFACTURING NONCONFORMANCES IDENTIFIED DURING THE DEVICE EVALUATION WAS IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. BASED ON THE REVIEW IT IS POSSIBLE NONCONFORMING PRODUCT WAS RELEASED INTO DISTRIBUTION. A FIELD ACTION ASSESSMENT WAS COMPLETED TO DETERMINE IF FIELD ACTION IS REQUIRED. IN ADDITION, PRODUCTION WAS NOTIFIED IN AN EFFORT TO HEIGHTEN THEIR AWARENESS. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE SUPPLIER PROVIDED THE FOLLOWING, "A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED, ALL RELEVANT DEFECTS HAVE BEEN DOCUMENTED. THE VISUAL EVALUATION OF THE DEVICE CONFIRMED THE CUSTOMER'S COMPLAINT. FURTHER INVESTIGATION DETERMINED THAT HUMAN ERROR DURING THE SOLDERING PROCESS WAS THE ROOT CAUSE. AWARENESS TRAINING/ RETRAINING WILL BE PERFORMED." PRIOR TO DISTRIBUTION, ALL CAPTURA BIOPSY FORCEPS WITHOUT SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.