JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 50CM MAXI-CURVED

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY.

Description of Event or Problem

A CUSTOMER REPORTED THAT DURING AN ENDOMYOCARDIAL BIOPSY, HE BELIEVES THERE WAS A GAP BETWEEN THE SHAFT AND THE HEAD OF THE FORCEPS THAT CAUGHT ON THE PATIENTS VALVE AND PULLED SOME TISSUE OUT. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE RECORDED RELATING TO THIS ISSUE. ONE OPENED SAMPLE WAS RETURNED BY THE CUSTOMER FOR REVIEW. UPON VISUAL INSPECTION IT WAS FOUND THAT THE BLUE OUTER JACKET WAS SEPARATED FROM THE SPRING SHAFT. THE COMPLAINT IS CONFIRMED. THE DEVICE WOULD NOT ACTUATE WHEN RECEIVED. DISTAL END OF DEVICE WAS SOAKED FOR FIFTEEN MINUTES IN ALCOHOL AND REMOVED. DEVICE WOULD THEN SLIGHTLY START TO OPEN UPON ACTUATION. JAW WAS MANIPULATED OPEN AND THEN THE DEVICE WAS SOAKED AGAIN AND PERIODICALLY ACTUATED. AFTER FINAL REMOVAL FROM ALCOHOL SOAK, THE DEVICE WOULD ACTUATE. ROOT CAUSE OF THE SEPARATION OF THE BLUE OUTER JACKET FROM THE SPRING SHAFT IS MOST LIKELY A FOREIGN SUBSTANCE (ORGANIC) CAUGHT IN THE SHAFT COILS CAUSING TENSION BETWEEN THE DISTAL TIP OF THE JAWZ AND THE BLUE OUTER JACKET. THIS CAUSED EXTENSIVE FORCE TO BE APPLIED TO THE SHAFT COILS AND NOT TO THE ACTUAL JAWZ FORCEPS WHICH LED TO THE BREAKAGE. A RESULT OF THE DEVICE NOT BEING THOROUGHLY RINSED. SINCE THIS ISSUE WAS BELIEVED TO BE CAUSED BY THE USER NOT THOROUGHLY RINSING WITH HEPARINIZED SALINE, NO CORRECTIVE ACTION IS NECESSARY. THE IFU HAS BEEN UPDATED SINCE THE MANUFACTURE OF THIS PRODUCT TO FURTHER STRESS THE IMPORTANCE OF CLEANING THE DEVICE UPON REMOVAL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT.