BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP

    MDR report key: 1221323 · Received October 26, 2008

    Report

    Report Number
    1221323
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    October 26, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCTOR TRIED TO LOAD A CLIP ON THE TYCO HEALTHCARE ENDO CLIP 3 BEFORE USING IT ON THE PATIENT AND REALIZED THAT IT WOULD NOT LOAD. IT APPEARED NOT TO CLOSE AT ALL, AT THE HANDLE. WE IMMEDIATELY REMOVED THE DEFECTIVE CLIP APPLIER FROM THE FIELD AND REPLACED IT WITH A NEW ONE THAT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP CLIP APPLIER GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * U8G01

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR