Description of Event or Problem · 1
THE 64 YEAR OLD PATIENT HAD A TRANSURETHRAL RESECTION OF THE PROSTATE IN 1990 WHICH CAUSED HIS INCONTINENCE. AN ARTIFICIAL URINARY SPHINCTER (AUS) WAS THEREFORE IMPLANTED IN 1991. MULTIPLE REVISIONS WERE PERFORMED ON THE AUS BEFORE IT WAS REPLACED IN NOVEMBER 1992. THE REPLACEMENT AUS EVENTUALLY BECAME NON-FUNCTIONAL AND WAS REMOVED AND REPLACED WITH THE CURRENT ON AUS ON MAY 25, 1993.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.