BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT

    MDR report key: 2081319 · Received April 28, 2011

    Report

    Report Number
    1717344-2011-00317
    Event Type
    Injury
    Date Received
    April 28, 2011
    Report Date
    April 25, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A VAGINAL HYSTERECTOMY, THE DEVICE JAWS BECAME LOCKED ON TISSUE. THE DEVICE WAS CUT FROM TISSUE IN ORDER TO REMOVE IT. THE PROCEDURE WAS CONVERTED TO AN OPEN HYSTERECTOMY. THE SURGEON USED CLAMPS AND SUTURES TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 191857L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other