BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP

    MDR report key: 2213776 · Received August 9, 2011

    Report

    Report Number
    2213776
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 9, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING AN AUTOSUTURE BRAND SMALL CLIP APPLIER (REF # 134046 LOT # P0J0402R), THE DOCTOR WENT TO APPLY A CLIP TO A VEIN, AND TWICE THE CLIP APPLIER FAILED TO DELIVER A CLIP, WHICH BRINGS THE BARE JAWS DOWN ON THE VESSEL CUTTING IT. WE HAVE FILED OTHER REPORTS OF THE SAME DEVICE THAT CONTINUES TO FAIL.THIS HAS BEEN AN ONGOING PROBLEM. WE HAVE SENT SEVERAL DEVICES BACK TO THE MANUFACTURER. THEY RESPONDED THAT THEY WERE LOOKING INTO THE SITUATION, BUT WE HAVE NOT HEARD ON ANY PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP CLIP APPLIER FZP COVIDIEN S-9.0 POJO4O2R

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR