BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ELECTROSURGICAL GENERATOR

    MDR report key: 2873448 · Received December 4, 2012

    Report

    Report Number
    2873448
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE GROUP LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE ELECTRICAL SURGICAL UNIT'S FOOT PEDAL WOULD NOT WORK "APPROPRIATELY". THE YELLOW CUT/BLEND PEDAL WOULD COAG, BUT NOT VERY WELL. THE BLUE COAG PEDAL WOULD NOT WORK AT ALL. EQUIPMENT WAS CHANGED OUT AND NEW EQUIPMENT IN PLACE WORKED APPROPRIATELY. THERE WAS NO PATIENT INJURY. EQUIPMENT WAS PULLED FROM SERVICE AND THE FACILITY'S BIOMED STAFF DETERMINED THE PIGTAIL CONVERTER WAS THE ISSUE FOR SOME UNKNOWN REASON. THIS EQUIPMENT WILL BE REPAIRED BY THE MANUFACTURER AS THE FACILITY BIOMED ONLY PERFORMS ELECTRICAL TESTING ON THIS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCETRIAD ELECTROSURGICAL GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE GROUP LP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NO OTHER THERAPIES