BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2060654 · Received April 8, 2011

    Report

    Report Number
    1717344-2011-00279
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 23, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A VAGINAL HYSTERECTOMY, THE DEVICE JAWS BECAME LOCKED WHILE ON TISSUE. IT IS UNK HOW THE DEVICE WAS REMOVED. TO DATE, THE SITE HAS NOT RESPONDED TO ADD'L QUESTIONS ASKED ABOUT THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 190091L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK