BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1904220 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00848
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 11, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN REC'D FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS REC'D, 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 AN LAVH PROCEDURE, THE DEVICE LOCKED ON TISSUE. THE SURGEON WAS NOT ABLE TO OPEN THE JAWS AND HAD TO CUT THE INSTRUMENT OUT OF THE TISSUE. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK