BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1873366 · Received October 15, 2010

    Report

    Report Number
    3006451981-2010-00080
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    June 25, 2010
    Report Date
    September 22, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE # : (B)(6). DATE OF INITIAL REPORT : (B)(6) 2010. 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 LAPAROSCOPIC PANCREATECTOMY AND SPLENECTOMY, IT WAS NOTED THAT THE LIGASURE HANDPIECE WAS ACTIVATED BUT WOULD NOT SEAL. THE SURGEON DISCONNECTED AND RECONNECTED THE DEVICE SEVERAL TIMES. HOWEVER, THE INSTRUMENT WOULD NOT WORK. A NEW HANDPIECE WAS OPENED AND USED. THE SITE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION ON THE INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S9MB046

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR