BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3221408 · Received June 28, 2013

    Report

    Report Number
    3006451981-2013-00201
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN OPEN PROCEDURE, THE HANDLE OF THE DEVICE JAMMED. IT IS UNK IF THE DEVICE WAS REMOVED FORM THE TISSUE AT THE TIME, AND IF SO, HOW THE DEVICE WAS REMOVED FROM THE TISSUE. THERE WAS NO INJURY TO THE PT. FURTHER, THE KNIFE BLADE WAS FOUND TO BE PROTRUDING FROM THE JAWS OF THE DEVICE WHEN IT WAS RECEIVED AT COVIDIEN FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295620 LIGASURE IMPACT LIGASURE VESSEL SEALING DEVICE GEI COVIDIEN LLC (SHANGHAI) S2LF022X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK