GASTROESOPHOGEAL ANTIREFLUX VALVE - ANGELCHIK PROSTHESIS
Received May 17, 1993 · Event occurred May 7, 1993
Report 5134 · MDR key 5134
Patient
67 YR
Narrative
Description of Event or Problem
ON 4/29/93, THE PATIENT WAS HOSPITALIZED WITH LOWER ABDOMINAL PAIN. THE ANGELCHIK DEVICE HAD APPARENTLY COME LOOSE AND MIGRATED INTO THE PEVIS AT SOME PREVIOUS DATE. THE PATIENT UNDERWENT SURGERY ON 5/3/93 FOR SIGMOID COLON AND UPPER RECTAL RESECTION WITH LOW PELVIC ANASTOMOSIS, LYSIS OF ADHESIONS, EXTRACTION OF MIGRATED PROSTHESIS, AND LEFT SALPINGO-OOPHERECTOMY. THE PATIENT EXPIRED 5/7/93.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: MATERIAL DEGRADATION/DETERIORATION, TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.