BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE TA PREMIUM 55

    MDR report key: 289422 · Received August 10, 2000

    Report

    Report Number
    1219161-2000-00734
    Event Type
    Injury
    Date Received
    August 10, 2000
    Date of Event
    June 20, 2000
    Report Date
    July 13, 2000
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    6/26/00 SURGEON A'S PREOP DIAGNOSIS: SMALL BOWEL OBSTRUCTION POST-OP DIAGNOSIS: SAME. PROCEDURE: LAPAROTOMY, BOWEL RESECTION WITH REANASTOMOSIS, LYSIS OF ADHESIONS, AND INSERTION OF A DRAINAGE TUBE. PRODUCT USED WAS A TA 55 4.8 WITH LOT# P9L458. SAME PT RETURNED 7/05/00 WITH SURGEON A.. PREOP DIAGNOSIS: SMALL BOWEL OBSTRUCTION. WITH POST OP: SAME WITH ADHESIONS. PROCEDURE: ABDOMINAL EXPLORATION WITH SMALL BOWEL RESECTION AND ENTEROLYSIS. PRODUCT USED IS A TA 90 4.8 2 RELOADS WITH LOT# P9A145 AND P8K34. THIS PT RETURNED TO OR IN 2000. PREOP DIAG: ANASTOMOTIC LEAK. POST-OP: SAME. PROCEDURE: LAPAROTOMY, BOWEL RESECTION, AND ILEOSOTOMY FORMATION. PRODUCT USED WAS COMPETITIVE. 200007-0372. THE INSTRUMENTS WILL BE DISASSEMBLED FOR ANALYSIS, BUT NO DESTRUCTIVE TESTING WILL BE CONDUCTED. THE INSTRUMENTS WILL BE REASSEMBLED AFTER THE ANALYSIS IS COMPLETE. THE INSTRUMENTS WILL THEN BE RETURNED TO HOSPITAL. PLEASE REFERENCE MEMO IN FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE TA PREMIUM 55 REUSABLE INSTRUMENT GAG UNITED STATES SURGICAL CORPORATION 010460 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other