130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE

Additional Manufacturer Narrative

THE THREE (3) INVOLVED CONCEPT HEATWAVE ELECTRODES ARE NOT BEING RETURNED TO CONMED CORPORATION FOR EVALUATION, AS THEY WERE DISCARDED AT THE END-USER FACILITY. IN ADDITION, NO VISUAL EVIDENCE (PHOTOGRAPHS) OF THE REPORTED "FIRE, BURNT/DAMAGED ELECTRODE TIPS" WAS PROVIDED BY THE END-USER. WITHOUT THE INVOLVED DEVICES, AN EVALUATION COULD NOT BE PERFORMED TO DETERMINE THE ROOT CAUSE AND/OR TO VERIFY THE REPORTED PROBLEMS. THIS LOT #667118 WAS MANUFACTURED ON 05-AUG-2015. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE COULD OR CONTRIBUTED TO ALLEGED INCIDENT. OF THE LOT CONTAINING (B)(4) UNITS, THERE WAS (B)(4) OTHER SIMILAR COMPLAINT WITH A QUANTITY OF (B)(4) RECEIVED FROM THE SAME CUSTOMER FOR THIS ITEM AND LOT NUMBER COMBINATION (SEE MDR #1017294-2015-00099). A REVIEW OF THE COMPLAINT HISTORY FOR THE DEVICE FAMILY SHOWS THERE HAVE BEEN NO SERIOUS INJURIES OR DEATH RELATED TO THIS REPORTED PROBLEM. THIS ALLEGED FAILURE MODE IS ADDRESSED IN THE FMEA AND THE SAFETY RISK HAS BEEN FOUND TO BE ACCEPTABLE. HOWEVER, DUE TO SIMILAR COMPLAINTS AN INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS REPORTED PROBLEM. THE HEATWAVE ELECTRODES ARE SINGLE-USE, DISPOSABLE MONOPOLAR ELECTRODES DESIGNED FOR USE WITH AN ELECTROSURGICAL GENERATOR VIA AN ELECTROSURGICAL PENCIL AND A DISPERSIVE ELECTRODE (PAD). THE HEATWAVE ELECTRODE IS INTENDED TO BE USED FOR ELECTRO-COAGULATION OF SOFT TISSUE IN SHOULDER, ANKLE, WRIST, ELBOW, AND KNEE ARTHROSCOPIC PROCEDURES. TO REDUCE THE RISK OF INSULATION DAMAGED AND PATIENT INJURY, THE DEVICE INSTRUCTION FOR USE (IFU) PROVIDES THE USER WITH THE FOLLOWING PRECAUTIONS AND WARNINGS: PRECAUTIONS: 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. CONTINUOUS FLOW OF IRRIGANT IS RECOMMENDED. FLUID FLOW ASSISTS IN REMOVING DEBRIS AS WELL AS COOLING THE FLUID IN THE JOINT AND ELECTRODE TIP BETWEEN ACTIVATIONS. MAINTAINING AN OUTFLOW IS IMPORTANT, ESPECIALLY IN SMALL JOINT SPACES. WARNINGS: 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. USE ABLATORS ONLY WITHIN PRESCRIBED GENERATOR SETTINGS. HIGH POWER GENERATOR SETTINGS, AND PROLONGED USE, MAY RESULT IN DAMAGE TO THE INSULATION, MELTING OF THE ELECTRODE TIP OR INCREASED RISK OF PATIENT BURNS. USE CARE WHEN INSERTING INTO AND WITHDRAWING THE ELECTRODE FROM A CANNULA TO AVOID THE POSSIBILITY OF DAMAGE TO THE DEVICES AND/OR INJURY TO THE PATIENT. DO NOT INSERT, WITHDRAW OR TOUCH THE ACTIVE TIP OF THE ELECTRODE WHEN POWER IS BEING APPLIED. THIS MAY RESULT IN AN UNINTENDED SURGICAL EFFECT, INJURY, OR DEVICE DAMAGE. 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. AVOID UNNECESSARY ACTIVATION BETWEEN TISSUE APPLICATIONS TO AVOID PATIENT INJURY. DO NOT PRY OR PULL TISSUE USING THE DEVICE. INSULATION MAY BE DAMAGED. ELECTRICAL SHOCK HAZARDS AND SAFETY CONSIDERATIONS: THIS EQUIPMENT IS CAPABLE OF PRODUCING A PHYSIOLOGICAL EFFECT AND IS FOR USE ONLY BY LICENSED PHYSICIANS TRAINED IN THE USE OF THIS DEVICE. EXAMINE ALL ACCESSORIES AND CONNECTIONS TO THE GENERATOR BEFORE USE. ENSURE ALL ACCESSORIES ARE PROPERLY AND SECURELY CONNECTED AND FUNCTION AS INTENDED. IMPROPER CONNECTION MAY RESULT IN ARCING, SPARKING, OR MALFUNCTION OF THE DEVICE, ANY OF WHICH CAN RESULT IN AN UNINTENDED SURGICAL EFFECT, INJURY, OR EQUIPMENT DAMAGE. DEVICES WERE DISCARDED AT USER FACILITY.

Description of Event or Problem

WHILE REPORTED AN INCIDENT IN THAT THE USER OBSERVED "FIRE FROM THE ELECTRODE" WHEN THE UNIT WAS ACTIVATED, WHICH ALLEGEDLY OCCURRED ON (B)(6) 2015, THE END-USER FACILITY ALSO MENTIONED THAT SIMILAR INCIDENTS HAD OCCURRED THREE (3) OTHER TIMES IN THE PAST FROM (B)(6) 2015. HOWEVER, WHEN INQUIRY WAS MADE TO THE END-USER FACILITY FOR INFORMATION ON PAST EVENTS INVOLVING THIS DEVICE, DETAILS REGARDING PATIENT PROCEDURES, DATES OF PROCEDURES, AND ANY DETAILS REGARDING THE MENTIONED PAST EVENTS ARE NOT AVAILABLE FROM THE END-USER FACILITY. WITHOUT SPECIFIC PATIENT/EVENT INFORMATION AND DETAILS DESCRIPTION OF INDIVIDUAL CASE, THE THREE (3) ALLEGED INCIDENTS ARE BEING REPORTED DUE TO POTENTIAL OF PATIENT INJURY WITH RECURRENCE. THERE WERE NO PATIENT OR USER INJURIES REPORTED WITH THESE ALLEGED INCIDENTS.