CAPTURA MINI BIOPSY FORCEPS W/O SPIKE

Additional Manufacturer Narrative

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 BRONCHOSCOPY, THE USER SELECTED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT IT SOUNDED LIKE SOMETHING SNAPPED AND MECHANICAL MECHANISM WAS DAMAGED THAT THE FORCEPS WOULD NOT FUNCTION, WOULD NOT OPEN/CLOSE APPROPRIATELY. THIS OCCURRED OUTSIDE OF THE BODY AS THEY ALWAYS CHECK DEVICES BEFORE THEY USE THEM. THE PROCEDURE WAS FINISHED WITH THE ANOTHER OF THE SAME DEVICE BUT DIFFERENT LOT NUMBER. 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 AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. ADDITIONALLY, 9 SEALED DEVICES FROM THE LOT NUMBER IN THE REPORT WERE RETURNED AND WILL BE EVALUATED AT THE SUPPLIER. 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 THE CUPS WERE IN THE OPEN POSITION. WHEN THE HANDLE WAS MANIPULATED, THE CUPS WOULD NOT CLOSE AND WERE STUCK OPEN. UNDER MAGNIFICATION IT WAS NOTED THAT THE CUPS WOULD NOT CLOSE. THE DEVICES WERE RETURNED TO THE SUPPLIER AND THE FOLLOWING WAS PROVIDED, "A TOTAL OF 10 DEVICES WERE RECEIVED; 1 DEVICE WAS UNPACKAGED, AND 9 DEVICES WERE UNUSED AND STILL SEALED IN POUCHES. VISUAL EVALUATION OF THE UNPACKAGED DEVICE SHOWED NO VISIBLE SIGNS OF DAMAGE TO THE JAW ASSEMBLY, COIL CABLE, OR HANDLE COMPONENTS. THE DEVICE HAD BEEN PREVIOUSLY MARKED WITH A BAND ON THE PEBAX COATING USING A PERMANENT MARKER. THE REMAINING 9 DEVICES WERE UNOPENED AND SEALED, SHOWING NO SIGNS OF DAMAGE. THE UNPACKAGED DEVICE WAS TESTED FOR FUNCTIONALITY IN THE U-BEND CONFIGURATION AND WAS UNABLE TO BE ACTUATED BY USING THE HANDLE. THE SPOOL WAS ABLE TO BE FULLY BOTTOMED OUT AGAINST THE THUMB LOOP, INDICATING THAT A BREAKAGE OCCURRED WITHIN THE INNER CONTROL WIRE ASSEMBLY. THE 9 PACKAGED DEVICES WERE REMOVED FROM THE POUCHES AND TESTED FOR FUNCTIONALITY IN THE U-BEND AND 2-COIL CONFIGURATIONS. ALL 9 DEVICES FUNCTIONED AS INTENDED, OPENING AND CLOSING FREELY WHEN ACTUATING THE HANDLE. FURTHER INVESTIGATION WAS REQUIRED IN ORDER TO DETERMINE THE CAUSE OF THE BREAKAGE OF THE DEVICE. USING A DREMEL TOOL WITH A 409 CUTOFF WHEEL, THE COIL CABLE WAS CUT BELOW THE FORK OF THE JAW ASSEMBLY IN ORDER TO EXAMINE THE WIRE LINK TO CONTROL WIRE SOLDER JOINT. THE BREAKAGE WAS FOUND TO HAVE OCCURRED AT THE SOLDER JOINT, AND WAS DUE TO EXCESSIVE GREENWHEELING, WHICH REMOVED MATERIAL FROM THE LINK WIRES AND CONTROL WIRE, WEAKENING THE JOINT. THE REMAINING 9 DEVICES THAT WERE RECEIVED SEALED, AFTER THE INITIAL FUNCTIONAL TESTING, WERE THEN SUBJECTED TO A SIMULATED LOAD TEST. ALL DEVICES PASSED, AND WERE THEN TESTED AGAIN FOR FUNCTIONALITY IN THE U-BEND AND 2-COIL CONFIGURATIONS. AFTER LOAD TESTING, ALL DEVICES REMAINED FULLY FUNCTIONAL AS INTENDED. IT WAS ALSO NOTED AFTER REVIEW OF THE DEVICE HISTORY, THAT ALL 160 DEVICES OF THE LOT PASSED THE LOAD TEST, AND WERE 100% TESTED FOR FUNCTIONALITY AT FQC. THE DEVICE HISTORY RECORDS FOR WERE REVIEWED AND WERE MANUFACTURED MARCH 2024. 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 USED DEVICE CONFIRMED THE REPORT. THE SUPPLIER PROVIDED THE FOLLOWING, "A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALIES. THERE WERE NO SIGNS OF DAMAGE NOTED DURING THE VISUAL EVALUATION OF THE DEVICES. THE FUNCTIONAL EVALUATION OF THE OPENED DEVICE FOUND THE DEVICE WAS UNABLE TO BE ACTUATED BY USING THE HANDLE. FURTHER EVALUATION FOUND THAT EXCESSIVE LINK WIRE MATERIAL WAS REMOVED DURING THE SOLDER JOINT GREENWHEELING PROCESS. THE CUSTOMER'S COMPLAINT OF THE OPENED DEVICE MALFUNCTIONING IS CONFIRMED. ROOT CAUSE WAS DETERMINED TO BE HUMAN ERROR. THE 9 POUCHED DEVICES WERE VISUALLY AND FUNCTIONALLY EVALUATED, ALL 9 DEVICES FUNCTIONED AS INTENDED. AWARENESS TRAINING WILL BE PERFORMED WITH THE OPERATORS." PRIOR TO DISTRIBUTION, ALL CAPTURA BIOPSY FORCEPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE PROPER WORKABILITY. 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.