BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LECTROVAC II 6-INCH

    MDR report key: 1000538 · Received February 11, 2008

    Report

    Report Number
    1717344-2008-00044
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 14, 2008
    Manufacturer
    COVIDIEN LP (BOULDER)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 02/11/2008. THE DEVICE HAS BEEN RECEIVED AND WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE DEVICE IS NOT SHUTTING OFF WHEN THE BUTTON IS RELEASED, AS IT SHOULD. THERE WAS NO INJURY TO SURGEON OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LECTROVAC II 6-INCH ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (BOULDER) 124355

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK