D
Patient 1
THE SAW BECAME HOT AS THE SURGEON WAS SAWING THE MANDIBLE. NO OTHER INSTRUMENT WAS AVAILABLE. WHILE COMPLETING THE PROCEDURE THE BODY OF THE INSTRUMENT BURNED A SPOT THE SIZE OF A QUARTER ON THE PTS LOWER LIP.DEVICE NOT 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: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, TELEMETRY FAILURE, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, INVALID DATA. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.