BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MULTIPLE CLIP APPLIER-23.8 CM, 20 MEDIUM

    MDR report key: 1190988 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03564
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIEPFLAP PROCEDURE, THE DEVICE SCISSORED CLIPS AND DAMAGED A VESSEL. THE VESSEL WAS REPAIRED BY SUTURES OR ANOTHER CLIP. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MULTIPLE CLIP APPLIER-23.8 CM, 20 MEDIUM NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1