BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1904217 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00865
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 26, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE BLADE BECAME STUCK AND WAS LOCKED ON TISSUE. 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) 190516L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK