BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 1982182 · Received January 18, 2011

    Report

    Report Number
    1717344-2010-01009
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC ESOPHAGOGASTRECTOMY, AN (B)(4) DEVICE WAS IN USE WITH THE GENERATOR AND THE GENERATOR PROVIDED END TONES, INDICATING COMPLETED SEAL CYCLES. OOZING WAS NOTED WHERE SEALING HAD BEEN ATTEMPTED. THE SURGEON INTRODUCED A NEW GENERATOR AND COMPLETED THE PROCEDURE WITH NO FURTHER DIFFICULTIES USING THE SAME HANDPIECE. THE SITE HAS INDICATED THE INCIDENT HANDPIECE WAS DISCARDED AFTER THE PROCEDURE. 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 76 YR (B)(4): LOT NUMBER UNKNOWN