BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE

    MDR report key: 2082837 · Received April 29, 2011

    Report

    Report Number
    1717344-2011-00328
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT 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 DURING A THYROIDECTOMY, THE BLUE INSULATION ON THE INSTRUMENT JAWS FLAKED OFF AND INTO THE PT CAVITY. THE MATERIAL WAS RETRIEVED AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE PRECISE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 198160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK