BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 1160704 · Received August 29, 2008

    Report

    Report Number
    1717344-2008-00407
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 4, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (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 REPORT STATES THAT DURING A HEPATIC RESECTION A FORCE TRIVERSE PENCIL, A FORCETRIAD GENERATOR AND TISSUELINK DEVICE WERE USED. THE PATIENT DRAPE WAS BURNED WHEN THE FORCE TRIVERSE PENCIL WAS ACTIVATED BECAUSE THE TISSUELINK DEVICE WHICH HAD BEEN PLACED ON THE DRAPE, ACTIVATED AS WELL. FORCETRIAD GENERATOR SETTINGS WERE 3, TRIVERSE:3, TISSUELINK: COAG 80W. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT NUMBER UNK| SALIENT SURGICAL TECHNOLOGIES TISSUELINK DEVICE| COVIDIEN FORCE TRIVERSE PENCIL