Description of Event or Problem · 1
STAFF AT SURGERY CENTER INFORMED OR SUPERVISOR THAT INSTRUMENTATION WRAPPED IN DOUBLE PULL-BACK POUCHES CONTAINED VISIBLE MOISTURE AND CONDENSATION AFTER STERILE PROCESSING. MFR REP CALLED IMMEDIATELY AND REPAIRED STERILIZER. STERILIZER FOUND TO HAVE VACUUM SETTING AT 1/2 OF ACCEPTABLE SETTING. ALL WRAPPED INSTRUMENTS FROM WEEK OF 7/25 TO 7/29 WERE RE-WRAPPED. DART TEST AND CHEMICAL INDICATORS DID NOT SHOW EVIDENCE A DEFECT OCCURRED. A DAILY LOG IS NOW KEPT OF TEST RESULTS FOR STERILIZER.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUN-94. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, FAILURE TO CYCLE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.