D
Patient 1
ON 1/6/95 PT UNDERWENT SURGERY FOR A BOWEL RESECTION. ON 1/16/95 PT RETURNED TO SURGERY FOR EXPLORATORY LAPAROTOMY. THE ANASTOMOSIS RING HAD BEEN COMPLETELY PASSED AT THIS TIME. THE ANASTOMOSIS SITE WAS TOTALLY DISRUPTED. PT WAS RETURNED TO OR FOR SIGMOID COLOSTOMY AND DRAINAGE OF ABSCESS. MEDICAL DEVICE REPORT COMPLETED. INCIDENT REPORT SENT TO RISK MANAGEMENT. INCIDENT REPORT TO COMPANY SALES REPRESENTATIVE. ADMINISTRATION AND BIO-MEDICAL NOTIFIED OF INCIDENT. DEVICES REMOVED FROM THE SHELF UNTIL INCIDENT IS RESOLVED.DEVICE 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.