BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2980510 · Received January 31, 2013

    Report

    Report Number
    3006451981-2013-00019
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 DURING A HYSTERECTOMY, THE JAWS COULD NOT BE RE-OPENED WHILE APPLIED TO TISSUE. THE SURGEON WAS ABLE TO ACTIVATE THE DEVICE IN ORDER TO RELEASE IT FROM THE TISSUE. THERE WAS NO REPORTED PT INJURY. THE DEVICE WAS RETURNED FOR EVAL WITH THE KNIFE BLADE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43706 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2JF001X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK