130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED FOR EVALUATION HOWEVER THE PROVIDED PHOTOGRAPHIC EVIDENCE EXHIBITS THE REPORTED EVENT. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A 2 YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF 2 EVENTS INVOLVING 3 DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF TWO REPORTS, REGARDING THREE DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 1,829 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.002. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: ELECTRODES MUST ONLY BE USED IN A CONDUCTIVE FLUID MEDIUM TO AVOID INSULATION DAMAGE. IF ANY VISUAL DEFECTS ARE NOTICED IN THE INSULATION, OR THE CERAMIC/INSULATION IS DAMAGED IN ANY WAY, STOP USING THE DEVICE IMMEDIATELY AND REPLACE THE DEVICE. DO NOT BURY ELECTRODE TIP AND INSULATOR IN TISSUE. THE ELECTRODE TIP MUST BE COMPLETELY SURROUNDED BY CONDUCTIVE FLUID WHEN ACTIVATED IN ORDER TO AVOID DAMAGE TO THE INSULATION. THE USER IS ALSO ADVISED TO USE CAUTION WHEN PROGRAMMING THE POWER SETTINGS. USE THE LOWEST POWER SETTING AND THE MINIMUM TISSUE CONTACT-TIME NECESSARY TO ACHIEVE THE APPROPRIATE SURGICAL EFFECT. HIGH POWER SETTINGS, AND PROLONGED USE MAY RESULT IN DAMAGE TO THE INSULATION, MELTING OF THE ELECTRODE TIP, OR PATIENT BURNS. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE CS-023 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5 WAS BEING USED ON APPROXIMATELY (B)(6) 2023 AND ¿WE ARE WAITING SOME INFO FROM THE CUSTOMER.¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. AFTER FURTHER ASSESSMENT IT WAS FOUND ¿REPORT OF ELECTRODE DAMAGE: WHILE USING THE CONCEPT HEATWAVE ELECTRODE DURING A SIMPLE KNEE ARTHROSCOPY I NOTICED SEVERAL PLASTIC FRAGMENTS SCATTERED THROUGHOUT THE JOINT THAT DETACHED FROM THE ELECTRODE INSULATION (WITHOUT HAVING STRAINED AND WITHOUT HAVING USED OTHER TOOLS AT THE SAME TIME). I USED BOTH COAGULATION AND CUTTING.¿ ALL FRAGMENTATION WAS RETRIEVED AND THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.