BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1850125 · Received September 21, 2010

    Report

    Report Number
    1717344-2010-00647
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 2, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2010. THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CYSTECTOMY, THE SURGEON SEALED AND THEN CUT TISSUE. WHEN THE SURGEON REMOVED THE DEVICE FROM THE PT HE REPORTED THAT THE KNIFE WAS NO LONGER WITHIN THE JAWS AND IT WAS PROTRUDING FROM THE SIDE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 186886L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK