BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1013602 · Received March 14, 2008

    Report

    Report Number
    1219930-2008-00222
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 21, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K06109*5
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. PATIENT SEX: UNK. ACCORDING TO THE REPORTER: THE STAPLER CUT THE BOWEL, BUT DID NOT FIRE STAPLES. CONSECUTIVE GUNS AND RELOADS WERE TRIED AND PROBLEM PERSISTED. MULTIPLE STAPLERS AND RELOADS WERE USED TO COMPLETE PROCEDURE. THE ENTEROTOMY WAS FORCED TO BE LARGER THAN USUAL DUE TO REPEATED CUTTING WITHOUT STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS N7M140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 60-3.5| PRODUCT ID#: 030458