BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2231301 · Received July 25, 2011

    Report

    Report Number
    1717344-2011-00613
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Report Date
    July 20, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT ACTIVATE. THE SURGEON OPENED A SECOND DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED WITH THE KNIFE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 203960LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK