BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3101774 · Received April 30, 2013

    Report

    Report Number
    3006451981-2013-00132
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 24, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 THE DEVICE STOPPED ACTIVATING DURING A PROCEDURE AND ERROR ALARMS WERE PROVIDED BY THE GENERATOR IN USE. THERE WAS NO PT INJURY REPORTED. THE DEVICE WAS RETURNED WITH THE KNIFE BLADE PROTRUDING FROM THE JAWS. THE SITE CONTACT COULD NOT PROVIDE ADD'L DETAILS REGARDING THE DEVICE OR INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187777 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2LF033X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK