BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1982184 · Received January 18, 2011

    Report

    Report Number
    1717344-2010-01010
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 22, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE, THE JAWS BECAME LOCKED AND THE KNIFE WAS PROTRUDING FROM THE JAWS OF THE DEVICE. THE SURGEON OPENED A SECOND DEVICE AND COMPLETED THE PROCEDURE WITH NO FURTHER DIFFICULTIES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 192326L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK