JAWZ EMB FORCEPS

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE BATCH RECORD WAS PERFORMED FOR (B)(4), IN-PROCESS AND FINISHED GOODS AND THERE WERE NO NON-CONFORMANCES OR CAPAS OPENED IN RELATION TO THE NATURE OF THE COMPLAINT. ALL DEVICES MET ALL (B)(4), IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT. THE RETURNED DEVICE WAS EVALUATED BY THE SUPPLIER. PER THE SUPPLIER, ¿THE DEVICE WAS RETURNED WITH THE INTRODUCER STILL ATTACHED. THE INTRODUCER WAS REMOVED AND THE DEVICE WAS LAID ACROSS THE WORK BENCH. THERE WERE SEVERAL SEVERE BENDS IN THE OUTER JACKET CAUSED BY OVER-ACTUATION. THE FORCEPS WOULD NOT OPEN. THE DISTAL END OF DEVICE WAS INSPECTED UNDER 10X MAGNIFICATION AND IT WAS CLEAR THAT THERE WAS DRIED FLUID PREVENTING THE JAWS FROM OPENING. THE JAWS WERE SOAKED IN HYDROGEN PEROXIDE AND THE DRIED FLUIDS WERE REMOVED WITH A RAZOR BLADE. ONCE A SIGNIFICANT AMOUNT OF DRIED FLUID WAS REMOVED, THE JAWS WERE ABLE TO OPEN AND CLOSE WHEN ACTUATED. THESE DEVICES ARE FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. THERE IS NO ROOT CAUSE INVESTIGATION AT THIS TIME. ONCE THE DEVICE WAS CLEANED WITH HYDROGEN PEROXIDE THE JAWS WERE ABLE TO OPEN AND CLOSE AS INTENDED EVEN WITH THE BENDS IN THE OUTER JACKET.¿

Additional Manufacturer Narrative

A REVIEW OF THE PACKAGE DEVICE HISTORY RECORD AND INSPECTION RECORDS WAS CONDUCTED AND NO SIMILAR CONCERNS WERE FOUND. THE RETURNED DEVICE WAS EVALUATED AND THE ISSUE WAS CONFIRMED SINCE THE BIOPSY JAWS DO NOT OPEN. THIS PRODUCT IS PURCHASED FULLY PACKAGED FROM A SUPPLIER. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN SENT TO THE SUPPLIER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE SUPPLIER PROVIDES THEIR EVALUATION AND CONCLUSIONS.

Description of Event or Problem

PATIENT ADMITTED FOR CARDIAC BIOPSY TO RULE OUT AMYLOIDOSIS. UPON ATTEMPT TO RETRIEVE TISSUE SAMPLE THE ENDOMYOCARDIAL BIOPSY FORCEP BECAME STUCK IN THE SUPERIOR VENA CAVA (SVC) RIGHT ATRIAL JUNCTION AND FAILED TO OPEN OR RELEASE DESPITE MULTIPLE ATTEMPTS TO OPEN UP. PATIENT WAS SUBSEQUENTLY ADMITTED EMERGENTLY TO THE OPERATING ROOM WHERE A STERNOTOMY AND SMALL VENOTOMY WAS COMPLETED TO REMOVE THE BIOPSY FORCEP.