Description of Event or Problem · 1
DURING EXPLORATION OF LEFT MEDIAL THIGH WOUND (SECONDARY TO VASCULAR ANTASTOMOSIS AND ORIF AND PLATING OF LEFT FEMUR) A PIECE FROM THE OVERHEAD SPOTLIGHT FELL INTO THE PATINETS WOULD. THE INCISION WAS IRRIGATED WITH A NACI AND CEFAZOLIN SOLUTION. TO DATE NO INFECTION HAS DEVELOPED. THE LIGHTS ARE INSPECTED QUARTERLY AND WAS LAST INSPECTED ON OCTOBER 15, 1992.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-92. SERVICE PROVIDED BY: INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION. 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: INVALID DATA. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.