BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 1040690 · Received May 8, 2008

    Report

    Report Number
    2647580-2008-00263
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 15, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDO
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHEN THE OPERATOR APPLIED THE INSTRUMENT, NO CLIP CAME OUT. THE INSTRUMENT CUT THE VESSEL WHICH RESULTED IN SOME BLOOD LOSS. THE PT SEX, DETAILS AND PROCEDURE TYPE WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP S-9.0 TITANIUM SURGICAL CLIP APPLIER GDO PONCE - USS P7M0171J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention