Description of Event or Problem · 1
STERIS WAS INSTALLED JULY 15, 1991 WAS USED UNTIL JAN 28, 1992 USING THE ELECTRONIC REPORT AS CYCLE COMPLETED. FEB. WE RECEIVED THE CHEMICAL INDICATORS WHICH DID NOT CHANGE COLOR ON THE FLEXIBLE SCOPE TRAY. MANY TELEPHONE CONVERSATIONS - 2/19/92 MACHINE WAS UP-GRADED. NEW TRAY SENT ON MARCH 9, 1992. APRIL 17, 1992 REPRESENTATIVE MADE AN ON-SITE VISIT TO CLEARIFY AND EXAM THE #1 TRAY. FOUND THE METAL ASPIRATOR CONNECTOR LOOSE - MACHINE CURRENTLY WORKING WITHOUT PROBLEMSDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. DATE LAST SERVICED: 01-FEB-92. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.