BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 3961005 · Received May 23, 2014

    Report

    Report Number
    3006451981-2014-00639
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2014. 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 ORIGINALLY REPORTED THAT PRIOR TO USE ON THE PT AND WHILE TESTING THE DEVICE, THE KNIFE BLADE COULD NOT BE MOVED AND WAS CONTAINED WITHIN THE JAWS. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS RETURNED TO COVIDIEN FOR EVAL WITH THE KNIFE BLADE EXPOSED FROM BEYOND THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309321 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S3FF008X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK