BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA SMALL APPLIER

    MDR report key: 1933277 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07271
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    April 27, 2009
    Report Date
    December 1, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST PROCEDURE THE SURGEON WAS CLIPPING THE MAMMARY ARTERY ON THE LEFT SIDE AND THE CLIP WOULD NOT ADVANCE. DURING REMOVAL OF THE APPLIER THE SURGEON CUT THROUGH THE LEFT MAMMARY ARTERY. THERE WAS NO OTHER INFORMATION PROVIDED BY THE CUSTOMER, THE DEVICE WAS FROM 2009 AND NO CONTACT INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT REPORTED FOR THAT SURGERY. THE DEVICE WILL BE RETURNING FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1