BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1191084 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03601
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/10/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC PROCEDURE, THE CLIPS WOULD NOT TIGHTEN DOWN. IT IS UNK HOW THEY COMPLETED THE PROCEDURE. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KK2F

    Patients

    Seq Age Sex Outcome Treatment
    1