Description of Event or Problem · 1
ON APRIL 13, 1993 A PHYSICIAN WAS PERFORMING A BILATERAL ARTHROSCOPY OF THE KNEE ON A 38 YEAR OLD MALE PATIENT. APPROXIMATELY THREE QUARTERS OF THE WAY THROUGH THE PROCEDURE THE LASER WAS ACTIVATED AND DOCTOR RECEIVED A BURN BETWEEN THE THUMB AND INDEX FINGER OF HIS LEFT HAND. THE PATIENT WAS NOT HARMED THE LASER WAS TURNED OFF AND THE CASE WAS CONTINUED USING CONVENTIONAL METHODS. AFTER COMPLETION OF THE PROCEDURE THE CURVED ORTHOPEDIC HANDPIECE WAS INSPECTED AND A BREAK WAS NOTED IN THE FIBER OPTIC CABLE WHERE THE CABLE ENTERED THE HANDLE AT THE REAR.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.