BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO PATH ILS

    MDR report key: 1759572 · Received July 12, 2010

    Report

    Report Number
    MW5016714
    Event Type
    Injury
    Date Received
    July 12, 2010
    Date of Event
    May 25, 2010
    Report Date
    July 12, 2010
    Manufacturer
    JOHNSON & JOHNSON HEALTH CARE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ANASTOMOSIS FORMATION AT THE SIGMOID COLON SITE, THE ILS 33 STAPLER MALFUNCTIONED CAUSING ADDITIONAL DAMAGE TO THE SIGMOID COLON. WHEN THE STAPLER WAS FIRED, IT DID NOT RELEASE AS IT IS DESIGNED TO DO. ATTEMPTS TO REPAIR THE DAMAGED PORTION WERE UNSUCCESSFUL, AND A COLOSTOMY WAS PERFORMED. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SMALL BOWEL RESECTION AND SIGMOID COLON RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PATH ILS ENDOPATH ILS 33MM STAPLER GDW JOHNSON & JOHNSON HEALTH CARE G4RP9K

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization