BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNEX 10X10 LOOP ELECTRODE

    MDR report key: 19018757 · Received April 1, 2024

    Report

    Report Number
    MW5153449
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 28, 2024
    Manufacturer
    GYNEX CORPORATION
    Product Code
    HGI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    32 YEAR OLD FEMALE ARRIVED TO OPERATING ROOM FOR SCHEDULED LEEP PROCEDURE. CAUTERY SETTINGS IN PREFERENCE CARD WERE LISTED AS "100/100 - VERIFY" UNDER EQUIPMENT SUBSECTION, AND "BOVIE COAG 90, CUT 90" IN RN NOTES SECTION; VERIFIED WITH SURGEON, BOVIE CONFIRMED TO BE SET AT 100/100. A SMALL GYNEX LOOP WAS USED TO TAKE MULTIPLE SPECIMENS AROUND THE CERVICAL OS. DURING THE PROCEDURE A GYNEX LOOP BROKE CAUSING AN INTERNAL VAGINAL BURN. THE SURGEON STATED THE BURN WAS CAUSED BY THE LOOP BENDING. PER IFU THERE IS NO DIRECTION ON WHAT TO SET LIMITS TO. THE VENDOR STATED THERE ARE NO HIGH LIMITS SET AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624009 GYNEX 10X10 LOOP ELECTRODE ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) HGI GYNEX CORPORATION 54-2105023-21

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female