QUAD CUTTER

Description of Event or Problem

IT WAS REPORTED THAT THE QUAD CUTTER BLADE WAS STUCK IN THE DISTAL TIP. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE BLADE IS STUCK IN THE SHAFT AND THE ACTUATING HANDLES ARE STUCK IN THE ACTUATING POSITION. THE BLADE IS CHIPPED AND DAMAGED BOTH AT THE DISTAL END AND ON THE PROXIMAL FINS. THE DISTAL END OF THE CUTTER IS DEFORMED ALONG THE CURVE, THE METAL IS BENT AND HAS SMALL FRACTURES. A FUNCTIONAL ASSESSMENT OF THE DEVICE FOUND THE ACTUATOR HANDLES ARE STUCK SO THE DEVICE IS NON-FUNCTIONAL. AFTER REMOVING THE BLADE THAT WAS STUCK, THERE WAS NO FURTHER DAMAGE OR DEFECTS OBSERVED ON THE DEVICE AND IT FUNCTIONED PROPERLY WHEN CHECKED WITH A NEW BLADE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OR AN INADVERTENT IMPACT EVENT INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.