BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2935538 · Received January 4, 2013

    Report

    Report Number
    1717344-2013-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 3, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT LONGER OPEN WHILE APPLIED TO TISSUE. THE TISSUE ADJACENT TO THE JAWS HAD TO BE EXCISED IN ORDER TO REMOVE IT FROM THE PT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5910 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 239033LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK