BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR RF ELECTRODE

    MDR report key: 23778202 · Received December 11, 2025

    Report

    Report Number
    23778202
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 12, 2025
    Report Date
    November 17, 2025
    Manufacturer
    STARMED CO.,LTD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A RADIO FREQUENCY ABLATION WITH DR. , PATIENT COMPLAINS OF SHARP PAIN. DR. STATED THE PROBE WAS OFF, BUT PATIENT DEVELOPED A BURN THE SIZE OF A PEA ON THE SURFACE OF THE SKIN. STAR RF ELECTRODE FIXED LOT # DE231113003 EXP. 2026-11-19. 18G/70MM/10MM, GROUNDING PAD LOT 231026014 EXP. 2026/09.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2776775 STAR RF ELECTRODE ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI STARMED CO.,LTD 18-07S10F DES231113003

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other