.197 IN X 10FT (5MM X 3.05M) AUTOCLAVABLE LIGHT GUIDE

Description of Event or Problem

CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE C3278 .197 IN X 10FT (5MM X 3.05M) AUTOCLAVABLE LIGHT GUIDE DEVICE WAS BEING USED DURING A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED THAT ¿THE PATIENT BURNED SINCE THE CONNECTOR PART WHICH IS CONNECTED TO LIGHT GUIDE CABLE GOT HOT. THE LIGHT SOURCE DEVICE IS SMITH & NEPHEW DEVICE.¿ AFTER FURTHER ASSESSMENT, IT WAS FOUND THAT THE LIGHT GUIDE WAS CONNECTED TO THE LIGHT TUBE AND THEN CONNECTED TO THE RETRACTOR. SEEMS THAT THE LIGHT GUIDE WAS TOUCHING THE PATIENT. THE BRIGHTNESS SETTING VALUE WAS 100. A 500XL XENON LIGHT SOURCE SMITH AND NEPHEW WAS USED. IT WILL BE LISTED AS A CONCOMITANT DEVICE. NO DETAILED INFORMATION REGARDING THE DEGREE OF THE BURN WAS KNOWN, BUT IT WAS VISIBLE. IT IS UNKNOWN IF THERE WAS ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY EXTENDED STAY AT THE HOSPITAL FOR THE MALE PATIENT. THE PROCEDURE WAS COMPLETED AND IT IS NOT KNOWN IF THERE WAS A DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

Additional Manufacturer Narrative

REPORTED EVENT IS INCONCLUSIVE. THE DEVICE WAS NOT RETURNED FOR EVALUATION TO DATE AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. A SERVICE HISTORY CAN NOT BE CONDUCTED DUE TO THE UNAVAILABILITY OF THE SERIAL NUMBER. A DEVICE HISTORY REVIEW CAN NOT BE CONDUCTED AS NO SERIAL NUMBER WAS PROVIDED. A RISK ANALYSIS CANNOT BE CONDUCTED SINCE CONMED DOES NOT OWN THE RISK DOCUMENTS FOR THIS DEVICE. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CONMED LIGHT GUIDES ARE NOT INTENDED FOR CONTACT WITH PATIENT. DO NOT USE IN SURGICAL PROCEDURES REQUIRING DIRECT ILLUMINATION OF THE EYE. HIGH INTENSITY LIGHT OUTPUT FROM THE LIGHT GUIDE OR ENDOSCOPE MAY CAUSE SEVERE EYE INJURY. ALWAYS POINT LIGHT GUIDE OR ENDOSCOPE TOWARD FLOOR WHEN NOT IN USE. BURN AND OR FIRE HAZARD: USE OF THE LIGHT GUIDE CAN CAUSE THE SCOPE TIP TO GET HOT AS A RESULT OF HIGH INTENSITY LIGHT. DO NOT ALLOW THE LIGHT EMITTING END OF THE LIGHT GUIDE TO CONTACT THE PATIENT, THE SURGICAL DRAPE OR ANY OTHER FLAMMABLE MATERIALS (E.G., GAUZE, ETC.). THIS CAN IGNITE THE DRAPE AND POTENTIALLY CAUSE SEVERE BURNS TO THE PATIENT AND / OR OPERATING ROOM PERSONNEL. THE DISTAL END OF THE LIGHT GUIDE MAY BECOME HOT TO THE TOUCH DURING USE. AVOID HAND OR TISSUE CONTACT AND / OR REDUCE LIGHT SOURCE BRIGHTNESS SETTING TO AVOID HIGH TEMPERATURES AT THIS AREA. DO NOT USE THE LIGHT GUIDE WITH INCOMPATIBLE EQUIPMENT OR ACCESSORIES THAT ARE NOT AUTHORIZED BY CONMED. DOING SO MAY VOID CERTIFICATIONS AND OR WARRANTIES. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Additional Manufacturer Narrative

THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

CONMED (B)(4) REPORTED ON BEHALF OF THE CUSTOMER THAT THE C3278 .197 IN X 10FT (5MM X 3.05M) AUTOCLAVABLE LIGHT GUIDE DEVICE WAS BEING USED DURING A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED THAT ¿THE PATIENT BURNED SINCE THE CONNECTER PART WHICH IS CONNECTED TO LIGHT GUIDE CABLE GOT HOT. THE LIGHT SOURCE DEVICE IS SMITH & NEPHEW DEVICE.¿ AFTER FURTHER ASSESSMENT, IT WAS FOUND THAT THE LIGHT GUIDE WAS CONNECTED TO THE LIGHT TUBE AND THEN CONNECTED TO THE RETRACTOR. SEEMS THAT THE LIGHT GUIDE WAS TOUCHING THE PATIENT. THE BRIGHTNESS SETTING VALUE WAS 100. A 500XL XENON LIGHT SOURCE SMITH AND NEPHEW WAS USED. IT WILL BE LISTED AS A CONCOMITANT DEVICE. NO DETAILED INFORMATION REGARDING THE DEGREE OF THE BURN WAS KNOWN, BUT IT WAS VISIBLE. IT IS UNKNOWN IF THERE WAS ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY EXTENDED STAY AT THE HOSPITAL FOR THE MALE PATIENT. THE PROCEDURE WAS COMPLETED AND IT IS NOT KNOWN IF THERE WAS A DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.