BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2063326 · Received April 1, 2011

    Report

    Report Number
    1717344-2011-00245
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    July 6, 2010
    Report Date
    March 7, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE, HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE MEDWATCH STATED: TWO HAND PIECES WITH THE SAME LOT NUMBER FAILED TO OPEN AFTER BEING FIRED DURING THE PROCEDURE. A THIRD HAND PIECE WITH A DIFFERENT LOT NUMBER WAS SUCCESSFULLY USED. THE PROCEDURE WAS A TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY. THERE WAS NO PT INJURY. THE SITE HAS INDICATED THEY HAVE NO ADD'L INFO AND THE DEVICE WILL NOT BE RETURNED FOR EVAL. THE OTHER DEVICE CAN BE REFERENCED ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK