BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUCLIP

    MDR report key: 4905230 · Received June 11, 2015

    Report

    Report Number
    4905230
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CLIPS WERE NOT CLIPPING TISSUE CORRECTLY. THE DEVICE WAS REMOVED FROM THE FIELD AND A NEW ONE ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381170 ACUCLIP APPLIER, SURGICAL, CLIP GDO COVIDIEN OMSA8 P5B0408X

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR