BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP II MED/LRG 10MM PISTOL GRIP

    MDR report key: 901464 · Received October 21, 2004

    Report

    Report Number
    1219930-2004-00303
    Event Type
    Malfunction
    Date Received
    October 21, 2004
    Date of Event
    January 21, 2004
    Report Date
    April 27, 2004
    Manufacturer
    NORTH HAVEN-USS
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    10/22/2004 INITIAL REPORT SENT TO FDA.

    Description of Event or Problem · 1

    REPORTEDLY, INSTRUMENT FIRED LOOSE CLIPS AND WERE REPLACED. PROCEDURE: LAP CHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP II MED/LRG 10MM PISTOL GRIP CLIP APPLIER FZP NORTH HAVEN-USS UNK N3M131

    Patients

    Seq Age Sex Outcome Treatment
    1 YR