Description of Event or Problem · 1
FIBEROPTIC LIGHT IN USE WITH A MICROSCOPE WENT OUT DURING SURGICAL PROCEDURE, DUE TO LAMP SOCKET FAILURE. SOME DELAY OCCURRED IN RESTORING LIGHT SOURCE. PHYSICIAN HAS ESTABLISHED THAT PATIENT HAS PROBABLE PERMANENT HEARING LOSS AT THE END OF POST-SURGICAL RECOVERY PERIOD. PHYSICIAN FEELS DELAY IN SURGICAL PROCEDURE PROBABLE CONTRIBUTING FACTOR IN HEARING LOSS. PHYSICIAN ESTABLISHED PROBABLE CONTRIBUTING FACTOR OPINION WITH FACILITY CONTACT PERSON ON 3/31/92, INITIATING THIS REPORTDEVICE 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: 01-JUL-91. SERVICE PROVIDED BY: INDEPENDENT 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, ELECTRICAL TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, ELECTRICAL PROBLEM, COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.