BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO TACKER

    MDR report key: 501741 · Received November 26, 2003

    Report

    Report Number
    MW1030424
    Event Type
    Death
    Date Received
    November 26, 2003
    Date of Event
    December 13, 2002
    Report Date
    November 26, 2003
    Manufacturer
    U.S. SURGICAL STEEL
    Product Code
    ---
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD LAPAROSCOPIC VENTRAL HERNINA REPAIR PERFORMED IN 2002. THE HOSPITAL REQUIRED THAT THE DR. ONLY USE PROTRUDING ENDO TACKERS SUPPLIED THROUGH U.S. SURGICAL STEEL. DR. HAD REQUESTED A SAFER FLAT END TACKER; HOWEVER, THE SUPPLIER ONLY PROVIDED THE PROTRUDING ENDO TACKER. THE FOLLOWING DAY THE PT EXPERIENCED SHARP PAIN WHEN FIRST REQUESTED BY MEDICAL STAFF TO STAND UP. THE PT'S CONDITION WORSENED IMMEDIATELY THEREAFTER. THE NEXT DAY DR. PERFORMED AN EXPLORATORY LAPAROTOMY, REMOVED THE MESH SECURED BY THE PROTRUDING ENDO TACKERS -CUTTING TO SHREDS SEVEN PAIR OF GLOVES IN THE PROCESS-, DETECTED THE PRESENCE OF LYSIS OF ADHESIONS, AND REPAIRED TWO SMALL BOWEL ENTEROTOMIES, AND CLOSED WITH VICRYL MESH AND RETENTON SUTURES. AFTER THE OPERATION, THE PT WORSENED AND PASSED AWAY 5 DAYS LATER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 11/26/03: THE PUNCTURE OF THE BOWEL BY THE PROTRUDING ENDO TACKERS INFECTED THE PT'S BODY SUCH THAT THEY DID NOT RECOVER. LIFE SUPPORT WAS REMOVED AND PT DIED SHORTLY THEREAFTER ON THE SAME DATE. DR LISTED THE CAUSE OF DEATH ON THE DEATH CERTIFICATE AS "PERITONITIS, COMPLICATION OF VENTRAL HERNIA REPAIR, AND UMBILICA HERNIA." MOREOVER, DR INDICATED ON THE DEATH CERTIFICATE THAT THE EVENT THAT RESULTED IN THE INJURY/DEATH AS "TACK FROM SURGICAL MESH PERFORATED BOWEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO TACKER ATTACHMENT MESH TO ABDOMINAL WALL --- U.S. SURGICAL STEEL UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| L