BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA

    MDR report key: 1190534 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03454
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    January 8, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/03/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE, THE CLIPS WOULD NOT HOLD ON THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JJ9W

    Patients

    Seq Age Sex Outcome Treatment
    1