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

Additional Manufacturer Narrative

CONMED RECEIVED THE THREE CONCEPT HEATWAVE ELECTRODES FOR EVALUATION ON (B)(6) 2015. VISUAL INSPECTION OF THE RETURNED DEVICES CONFIRMED THE SIDE OF EACH SHAFT WAS BURNT AND MELTED IN APPEARANCE AND A PORTION OF THE COATING WAS MISSING. UPON FURTHER ANALYSIS BY R&D ENGINEERING ON 11/11/2015 USING MICROSCOPIC INSPECTION, LONGITUDINAL MARKS ALONG THE LENGTH OF THE SHRINK TUBING WERE OBSERVED. AN INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. THIS DEVICE WAS MANUFACTURED ON 17-APR-2015 IN A LOT OF (B)(4) UNITS. (B)(4)). A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. THERE HAVE NOT BEEN ANY OTHER ADVERSE EVENTS REPORTED FOR THIS DEVICE. ONE OTHER COMPLAINT REPORT WAS OPENED FOR THIS DEVICE AND LOT NUMBER COMBINATION WHEN TWO (2) ADDITIONAL UNITS WERE RETURNED UNOPENED/UNUSED. THIS FAILURE MODE IS ADDRESSED IN THE FMEA AND THE SAFETY RISK HAS BEEN FOUND TO BE ACCEPTABLE. THE PRODUCT INSERT PROVIDES THE FOLLOWING PRECAUTION: 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.

Description of Event or Problem

IT WAS FIRST REPORTED BY THE CUSTOMER ON (B)(6) 2015, THAT THREE CONCEPT HEATWAVE ELECTRODES BURNED OUT DURING A SINGLE SURGICAL PROCEDURE BEFORE THE ELECTRODE COULD BE USED ON THE PATIENT. THERE WAS NO PATIENT IMPACT. ANALYSIS OF THE RETURNED ELECTRODES BY THE R&D ENGINEER ON (B)(6) 2015, FOUND THAT THERE WAS AN INSULATION FAILURE OF THE SHRINK TUBING.