BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE TA PREMIUM 55

    MDR report key: 289563 · Received August 10, 2000

    Report

    Report Number
    1219161-2000-00736
    Event Type
    Death
    Date Received
    August 10, 2000
    Date of Event
    June 20, 2000
    Report Date
    August 7, 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

    6/9/2000 PT ADMITTED WITH ACUTE ABDOMINAL PAIN. POST-OP DIAGNOSIS: PERFORATION OF POSTERIOR WALL. PROCEDURE: LAPAROTOMY, REPAIR OF THE POSTERIOR WALL WITH SURGEON B. USED WAS A TA 55 3.5. PT HAS RE-OPERATION WITH SURGEON A IN 2000 FOR ABDOMINAL ABCESS. POST-OP DIAGNOSIS: SAME. PROCEDURE: ABDOMINAL EXPLORATION WITH LIVER BIOPSY. COMPETITIVE PRODUCT USED. PT RETURNED OPERATING ROOM WITH SURGEON A IN 2000 FOR ABNDOMINAL DRAINAGE OCCURRING. POST-OP DIAGNOSIS: LEAKAGE AT RESECTION SITE. PROCEDURE: EXPLORATORY LAPAROTOMY, OVERSEW OF LEAKAGE SITE AND INSERTION OF JB TUBE. COMPETITIVE PRODUCT USED. PT RETURNED TO SURGERY WITH SURGEON A IN 2000 WITH INFECTED ABDOMINAL INCISION. POSTOP DIAGNOSIS: SMALL BOWEL INFARCT. PROCEDURE: EXPLORATORY LAPAROTOMY. NO STAPLING PRODUCT USED. PT EXPIRED ON 6/24/2000. 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 INTACT TO HOSP. 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 22 YR Death