BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUME PEN ULTRA

    MDR report key: 24544082 · Received March 9, 2026

    Report

    Report Number
    MW5184821
    Event Type
    Injury
    Date Received
    March 9, 2026
    Report Date
    March 3, 2026
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: IT WAS REPORTED THAT, DURING GENDER AFFIRMING BILATERAL MASTECTOMY WITH FREE NIPPLE GRAFT, THERE WERE 2 UNITS IN USE. EACH UNIT HAD A NON-MEDTRONIC PEN PLUGGED INTO THE MONOPOLAR PORT. EACH UNIT ALSO HAD A NON-MEDTRONIC REM PAD PLUGGED INTO THE REM PAD PORT. THE NON-MEDTRONIC REM PAD WAS PLACED ON THE PATIENTS' UPPER THIGH. THE MONOPOLAR SETTINGS WERE SET TO 60/60. ACCORDING TO THE NURSE THE PATIENT SUDDENLY STARTED TO BRADY DOWN WHILE USING BOTH HANDPIECES. ANESTHESIOLOGIST ASKED THEM TO STOP WHILE TRYING TO FIGURE OUT WHAT WAS GOING ON. THE PATIENT ENDED UP IN ASYSTOLE AND CHEST COMPRESSIONS HAD TO BE PERFORMED. ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS ACHIEVED AND THE PATIENT WAS BROUGHT TO THE PACU (POST-ANESTHESIA CARE UNIT) EXTUBATED. THE SURGICAL TIME AND HOSPITALIZATION WERE EXTENDED, AND PATIENT IS NOW IN THE ICU. PT CODE: 4442. DEVICE CODE: 3189. REF REPORT: MW5184822.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603767 PLUME PEN ULTRA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION PLPUL2020 (PLUME PEN ULTRA)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown