TRIPLE OPTION HANDPIECE PENCIL

Additional Manufacturer Narrative

THE USED DEVICE WAS RETURNED WITH ITS ORIGINAL PACKAGING TO CONMED FOR EVALUATION. THE REF AND LOT NUMBERS WERE VERIFIED FOR THIS PRODUCT FROM THE PACKAGING. THROUGH VISUAL INSPECTION OF THE DEVICE, NO DEFECTS WERE OBSERVED IN THE DEVICE. FOR A FUNCTIONAL EVALUATION, THE DEVICE WAS CONNECTED TO A CONMED SYSTEM 7500 ELECTROSURGICAL UNIT. IMMEDIATELY AFTER CONNECTION, CONTINUOUS ACTIVATION OF THE CUT MODE WAS INDICATED. FOLLOWING THIS, THE DEVICE WAS CAREFULLY DISMANTLED AND THE NEUTRAL WIRE WAS FOUND TO BE CROSSING AND COMPRESSING INTO THE CUT TRACE WIRE, WHERE THE WIRES ARE SOLDERED TO THE BUTTON PCB BOARD. FURTHER TESTING WITH A MULTIMETER VERIFIED A SHORT CIRCUIT BETWEEN THE NEUTRAL AND CUT WIRING. WHEN PRESSURE WAS APPLIED TO THE CROSSED WIRES, CONTACT BETWEEN THE NEUTRAL WIRE AND CUT TRACE WIRE ON THE PCB BOARD, CAUSED CONTINUITY. ADDITIONAL INVESTIGATION FOUND THE CROSSED WIRES, WHICH WERE CLOSELY EXAMINED, APPEARED TO BE MELTED TOGETHER. THE WIRES WERE STUCK TOGETHER AT THE POINT WHERE THE INSULATION WAS MELTED. THE WIRES WERE THEN SEPARATED AND THE INSULATION WAS COMPROMISED, EXPOSING BARE WIRE ON BOTH WIRES. THEREFORE, PRELIMINARY INVESTIGATION CONCLUDED THAT THE PROBABLE CAUSE OF THE SHORT CIRCUIT AND CONTINUOUS ACTIVATION WAS A COMBINATION OF MELTED/COMPROMISED WIRE INSULATION ON THE CUT AND NEUTRAL WIRES CONNECTED TO THE PCB BOARD, AND COMPRESSION FORCE ON THE WIRES WHEN ASSEMBLED INTO THE HANDLE HOUSING. A REVIEW OF THE MANUFACTURING DOCUMENTS HAS VERIFIED THE DEVICES WERE PRODUCED PER CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. CONFIRMATION WAS RECEIVED FROM THE QUALITY ENGINEER THAT ALL PARTS ARE TESTED FOR ELECTRICAL TEST, CONTINUITY TEST AND BEAMS TEST. A HISTORICAL REVIEW OF THIS DEVICE REVEALED A TOTAL OF (B)(4) SIMILAR REPORTS IN WHICH (B)(4) DEVICES HAVE BEEN CONFIRMED IN THE PAST TWO YEARS. (B)(4). A RISK ANALYSIS WAS PERFORMED AND FOUND THIS FAILURE MODE AND OCCURRENCE LEVEL TO BE ACCEPTABLE AND CONSISTENT WITH CURRENT RISK DOCUMENTS. THE INSTRUCTIONS FOR USE ADVISE THE USER OF THE FOLLOWING. TO PREVENT ACCIDENTAL BURNS, DO NOT ACTIVATE GENERATOR UNTIL ELECTRODE IS SECURE AND IN POSITION TO DELIVER ENERGY TO TARGET TISSUE. TURN OFF GENERATOR BEFORE ATTEMPTING TO REMOVE ELECTRODE. ALWAYS PLACE ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION, SUCH AS A HOLSTER, WHEN NOT IN USE, TO AVOID BURNS. DO NOT PULL ON OR STRETCH THE HANDPIECE CORD. THESE DEVICES SHOULD BE INSPECTED BEFORE USE AND DISCARDED IF DAMAGED. TO REVIEW THIS TYPE FAILURE, A PROCESS ANALYSIS INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM.

Description of Event or Problem

DURING THE PROCEDURE, THE PHYSICIAN WAS USING AN ABC HANDPIECE. WHILE NONE OF THE BUTTONS WERE BEING ENGAGED, THE HANDPIECE WAS STILL ON. THE HANDPIECE WAS DISCARDED AND A NEW ABC HANDPIECE WAS BROUGHT TO THE FIELD. THE SECOND HANDPIECE WORKED WITHOUT ANY INCIDENTS. ALTHOUGH THERE WAS A PROCEDURAL DELAY OF 3 MINUTES, THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS MADE BASED ON A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.