BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK DISPOSABLE IMA/ENT 3/4" NEEDLE ELECTRODE STERILE ELECTROSURGICAL ELECTRODE

    MDR report key: 19537060 · Received June 14, 2024

    Report

    Report Number
    19537060
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 21, 2024
    Manufacturer
    TELEFLEX, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE TELEFLEX NEEDLE ELECTRODE TIP WAS NOTED TO HAVE A LARGE SPARK, THE SETTING WAS AT 60, THE STAFF LOWERED TO 40; IT STILL HAD A SPARK. TELEFLEX TIP THEN SWITCHED OUT WITH NO RESOLUTION. THE BOVIE PENCIL, BOVIE TIP AND BOVIE MACHINE WAS CHANGED OUT AND MEGADYNE PAD NOT USED. A BOVIE PAD PLACED; HOWEVER, THE SURGEONS DID NOT NEED TO BOVIE ANYMORE, SO NOT SURE IF THAT RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368492 WECK DISPOSABLE IMA/ENT 3/4" NEEDLE ELECTRODE STERILE ELECTROSURGICAL ELECTRODE ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) HGI TELEFLEX, INC. 1022Z

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown