CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

Description of Event or Problem

DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE HANDLE BROKE DURING THE PROCEDURE. THERE WAS A LOUD CRACK FROM THE HANDLE. THE FORCEP WOULD NOT CLOSE PROPERLY. THE FORCEP HAS TO BE OPENED AND CLOSED SEVERAL TIMES TO GET THEM TO CLOSE PROPERLY. A NEW FORCEP WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 05/30/2023 AND IT WAS NOTED THAT THE CUPS WERE IN THE OPEN POSITION (STUCK OPEN) AND WOULD NOT CLOSE FULLY WHEN THE HANDLE WAS MANIPULATED [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

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. 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 CUPS WERE LEFT PARTIALLY OPENED BUT THERE APPEARED TO BE NO OTHER VISUAL SIGN OF DAMAGE TO THE DEVICE. DURING A FUNCTIONAL TEST, THE CUPS WOULD OPEN, HOWEVER, THEY WOULD NOT CLOSE FULLY WHEN THE HANDLE WAS MANIPULATED. ADDITIONALLY, WHEN THE HANDLE WAS MANIPULATED, WE COULD FEEL AND HEAR A POP IN THE HANDLE WHEN TRYING TO CLOSE THE FORCEPS. UNDER MAGNIFICATION, WE CAN SEE THAT THE CUPS ARE STUCK IN A PARTIALLY OPEN STATE. A FUNCTION TEST IN THE ENDOSCOPE WAS NOT POSSIBLE, DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER INVESTIGATION, AND THE FOLLOWING WAS PROVIDED, "NO VISIBLE ANOMALIES WERE OBSERVED IN THE JAW ASSEMBLY, COIL CABLE, COATING, OR HANDLE COMPONENTS. DEVICE WAS EVALUATED IN THE U-BEND POSITION AND WAS UNABLE TO BE ACTUATED BY MANIPULATING THE HANDLE. HANDLE SPOOL COULD BE MOVED FREELY ALONG STEM, BUT JAWS WERE NOT RESPONSIVE. AFTER REMOVAL OF HANDLE, DEVICE JAWS WERE ABLE TO BE ACTUATED FREELY BY MANIPULATION OF THE LINK WIRES. HANDLE SPOOL HALVES WERE CAREFULLY SEPARATED USING NON-SERRATED NEEDLE NOSE PLIERS. THE CLIP WAS SEATED IN THE APPROPRIATE SLOT WITHIN THE SPOOL AND SWAGES WERE VISIBLE IN PUSHROD ON EITHER SIDE OF THE CLIP. THE PUSHROD/CLIP ASSEMBLY WAS NOT ATTACHED TO THE DRIVE WIRES AND WAS ABLE TO BE REMOVED EASILY WITH NO USE OF FORCE. THE DRIVE WIRES WERE THEN MEASURED WITH DIGITAL CALIPERS, AND WERE VERIFIED TO BE AT THE PROPER LENGTH FROM THE PROXIMAL END OF THE CABLE, WHICH CONFIRMED THAT THE WIRES WERE MADE CORRECTLY. AN EVALUATION OF THE TESTING DATA FROM RELEVANT PRODUCTION DATES SHOWED THAT THE EQUIPMENT WAS OPERATING PROPERLY AND PRODUCING PARTS WITH PULL TEST VALUES IN THE ACCEPTABLE RANGE. CAPTURA PRO DEVICES ARE 100% TESTED FOR FUNCTIONALITY DURING FQC INSPECTION. IT IS UNKNOWN HOW THE PUSHROD/CLIP ASSEMBLY DETACHED FROM THE DRIVE WIRES IF OPERATED UNDER WITHIN THE PARAMETERS OF NORMAL ACTUATION FORCE." THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED. THE DEVICE WAS MANUFACTURED JANUARY 2023. NO RELEVANT DEFECTS WERE 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 DEVICE CONFIRMED THE REPORT FOR UNABLE TO OPEN AND/OR CLOSE THE FORCEPS JAWS. THE SUPPLIER PROVIDED THE FOLLOWING, "ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT REVEAL ANY RELEVANT DEFECTS. A VISUAL EVALUATION OF THE DEVICE DID NOT NOTE ANY ANOMALIES. THE FUNCTIONAL EVALUATION OF THE DEVICE CONFIRMED THE CUSTOMERS COMPLAINT. FURTHER EVALUATION OF THE DEVICE DISCOVERED THAT THE PUSHROD/CLIP ASSEMBLY WAS NOT ATTACHED TO THE DRIVE WIRES, IT IS UNKNOWN HOW THE PUSHROD/CLIP ASSEMBLY DETACHED FROM THE DRIVE WIRES. CAPTURA PRO DEVICES ARE 100% INSPECTED FOR FUNCTIONALITY PRIOR TO PACKAGING AND SHIPMENT." 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 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.