BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED APPLIER

    MDR report key: 1122031 · Received August 14, 2008

    Report

    Report Number
    3005075853-2008-01200
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE JAW OF CLIP WAS NOT PROPERLY OPENED. CONSEQUENTLY, THE CLIPPED VESSEL WAS TORN. THE LAST 7 CLIPS WERE LEFT. THERE WAS NO SERIOUS OUTCOME BECAUSE SURGEON DEALT WITH IT ADEQUATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MED APPLIER GDO ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1