BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1903070 · Received November 12, 2010

    Report

    Report Number
    1717344-2010-00847
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 29, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE 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 CHOLECYSTECTOMY, THE JAWS OF THE DEVICE BECAME LOCKED AND COULD NOT BE OPENED. THE DEVICE WAS CUT FROM TISSUE IN ORDER TO REMOVE IT. THE SURGEON OPENED ANOTHER DEVICE AND FINISHED THE PROCEDURE WITH NO FURTHER INCIDENT. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 192606L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK