BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ENT

    MDR report key: 2854150 · Received October 26, 2012

    Report

    Report Number
    2854150
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 25, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US

    Narratives

    Description of Event or Problem · 1

    AT THE BEGINNING OF THE MONTH, OR STAFF REPORTED AN INTERMITTENT PROBLEM WITH A GYRUS G400 RF GENERATOR NOT DELIVERING ENERGY DURING A CASE. DIFFERENT CUTTING FORCEPS WERE TRIED AND WORKED FOR A WHILE BUT FAILED AGAIN. HOWEVER, G400 GENERATOR WOULD LOOK AND SOUND LIKE ENERGY WAS BEING DELIVERED NORMALLY. CUTTING FORCEPS WERE SAVED FOR THE REP TO EXAMINE. THE REP CAME IN WITH AN ENGINEER FROM GYRUS AND MARKETING MANAGER WHO IS IN CHARGE OF THE ENERGY DIVISION TO OBSERVE CASES AND VERIFY PROBLEM. AT A LATER DATE, THE REP INFORMED OR STAFF THAT GYRUS IDENTIFIED A PROBLEM WITH A PARTICULAR CIRCUIT IN THE CUTTING FORCEPS. AS SUCH, STAFF WAS TOLD CUTTING FORCEPS MANUFACTURED AFTER THE BEGINNING OF THIS MONTH WILL HAVE UPDATED CIRCUITRY TO CORRECT IDENTIFIED ISSUE OF CEASING TO DELIVER ENERGY PERI-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS ENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES, CUTTIN GEI GYRUS ACMI, INC. G400 470199FE
    2 GYRUS ENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES, CUTTIN GEI GYRUS ACMI, INC. G400 428982CE
    3 GYRUS ENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES,CUTTING GEI GYRUS ACMI, INC. G400 464892FE

    Patients

    Seq Age Sex Outcome Treatment
    1 *