BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1954419 · Received December 14, 2010

    Report

    Report Number
    3006451981-2010-00096
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 15, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE CLOSED AND WOULD NOT OPEN AGAIN. NO FURTHER INFO WAS AVAILABLE FROM THE SITE AS TO HOW THE DEVICE WAS REMOVED. 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 LP (VALLEYLAB) S0EB041P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK