BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA MED

    MDR report key: 2003964 · Received March 1, 2011

    Report

    Report Number
    3005075853-2011-00789
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 10, 2011
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MASTECTOMY PROCEDURE, THE CLIPS WERE NOT STAYING IN THE JAWS WHEN THEY WERE FEED BY THE AUTO FEEDER. THE CLIPS WERE NOT SEATED IN THE JAWS, THEY WOULD FALL OUT. THEY DID NOT FALL INTO THE PATIENT. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. THE DEVICE WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1