BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA STAPLER

    MDR report key: 2003517 · Received February 21, 2011

    Report

    Report Number
    MW5019524
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO GIA STAPLER - (B)(4), LOT: N0J0378 - WITH RELOAD ENDO GIA UNIVERSAL ROTICULATOR 60-3.5 -(B)(4), LOT: NOL0187- CLAMPED ONTO PATIENT'S BOWEL AND COULD NOT OPEN IT. SURGEON PULLED STAPLER FROM BOWEL ONE SIDE AT A TIME WITHOUT TEARING OR INJURING THE BOWEL. NO HARM TO PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA STAPLER ENDO STAPLER GDW COVIDIEN N0J0378
    2 ENDO GIA UNIVERSAL ROTICULATOR RELOAD GDW COVIDIEN NOL0187

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other