BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTCEPS

    MDR report key: 2972459 · Received February 14, 2013

    Report

    Report Number
    2972459
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING USE, FOR FIRST TONSIL REMOVAL ENCOUNTERED NO PROBLEM. DEVICE WORKING FINE, AS WELL AS THE STARION MACHINE.AT SECOND TONSIL FOR REMOVAL, THE ENTCEPS DID NOT WORK. THE STARION MACHINE HAD THE LIGHT ON, TO SHOW IT WAS WORKING, BUT THE GREEN LIGHT DID NOT ENGAGE WHEN PEDAL WAS PUSHED TO INDICATE THAT THE ENTCEPS WERE GOING TO WORK.REPLACED THE DISPOSABLE, AND IT THEN WORKED.DID TEST ENTCEP #1 AT END OF CASE OUTSIDE OF PATIENT AND IT STILL DID NOT WORK.THE STARION MACHINE WAS ACTIVELY ENGAGED WITH ALL LIGHTS IN ORDER AND WORKING, SO IT APPEARS THAT THE DISPOSABLE WAS THE PROBLEM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TONSILLECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66370 ENTCEPS ELECTROSURGICAL, ACCESSORY, FORCEPS GEI MICROLINE SURGICAL, INC. * 206009

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR STARION ESU GENERATOR