BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1900059 · Received November 9, 2010

    Report

    Report Number
    3006451981-2010-00091
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HYSTERECTOMY, THE SURGEON SEALED, GOT AN END TONE FROM THE GENERATOR BUT WHEN THEY WENT TO REMOVE, THE JAWS WOULD NOT OPEN. THE DEVICE HAD TO BE CUT OUT OF THE TISSUE. THERE WAS NO NEGATIVE IMPACT TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S9D0021

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR