BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2082679 · Received April 28, 2011

    Report

    Report Number
    1717344-2011-00324
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 6, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A FEW SUCCESSFUL SEALS AND CUTS, THE CUTTING BLADE WOULD NOT DEPLOY AND THE JAWS WOULD NOT OPEN. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION ON THE INCIDENT WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 203382X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK