D
Patient 1
ON 1/9/95 PT UNDERWENT SURGERY FOR A SEGMENTAL RESECTION. AN ANASTOMOTIC DEVICE WAS USED. ON 1/17/95 PT UNDERWENT SURGERY FOR DEHISCENCE OF ANASTOMOTIC SITE. DEVICE EXPELLED AFTER 10 DAYS. PT HAD SIGMOID COLOSTOMY PERFORMED. AT THE TIME OF SECOND SURGERY, THE DISTAL PORTION OF THE ANASTOMOTIC DEVICE WAS NOT TOTALLY ATTACHED, WITH LEAKAGE AT THE ANASTOMOSIS SITE. REMOVAL OF IMPLANT WITH AN END-TO-END ANASTOMOSIS. INCIDENT REPORT AND MEDICAL DEVICE FORMS COMPLETED AND FORWARDED TO RISK MANAGEMENT. ADMINISTRATION NOTIFIED. DEVICES REMOVED FROM SHELF PENDING FURTHER INVESTIGATION. COMPANY REPRESENTATIVE NOTIFIED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.