Description of Event or Problem · 1
TISSUE EXPANDER INSERTED SEPTEMBER, 1992 FOR REPAIR OF ABDOMINAL DEFORMITY. ON DECEMBER 15, 1992 SHE WAS TAKEN TO SURGERY FOR NECROSIS OF RIGHT ABDOMINAL ADVANCEMENT FLAP. DURING THE COURSE OF SURGERY, THE ABDOMINAL TISSUE ESPANDER WAS REMOVED AND FOUND TO BE DEFECTIVE. THE EXPANDERS WERE LEAKING AT THE SUPERIOR BORDER AT JUNCTION OF SIDE WALLDEVICE LABELED FOR SINGLE USE. 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: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.