300W LS INTEGRA LUXTEC, INC.

THE CUSTOMER REPORTS THAT THE HOSPITAL PERSONNEL WERE USING A LUXTEC (B) (4) XENON LIGHT SOURCE IN CONJUNCTION WITH A FIBER OPTIC (B) (4) PROXENON HEADLIGHT CABLE ((B) (4)) AND A PRO XENON HEADLIGHT FOR ILLUMINATION DURING SURGERY. THE (B) (4) CABLE INSERTS INTO THE STORZ PORT OF THE LIGHT SOURCE TURRET. THE SURGICAL SERVICES MANAGER CONFIRMED VIA TELEPHONE THAT AT SOME POINT DURING THE PROCEDURE, A HOSPITAL EMPLOYEE WAS DISCONNECTING THE HEADLIGHT CABLE (END THAT CONNECTS TO THE LIGHT SOURCE) FROM THE SURGEON AND THE END OF THE CABLE CONTACTED THE EMPLOYEE'S FOREARM, CAUSING A 2ND-3RD DEGREE BURN THAT BLISTERED AND LATER OPENED. THE EMPLOYEE REFUSED DIAGNOSIS AND TREATMENT FOR THE BURN. THE HOSPITAL BIOMEDICAL PROFESSIONAL CHECKED OUR EQUIPMENT AND FOUND IT TO BE WITHIN NORMAL WORKING CONDITIONS. THERE WAS NO PT INJURY.

THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED ON THE REPORTED INFO.