BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMEPEN

    MDR report key: 23580551 · Received November 18, 2025

    Report

    Report Number
    1320894-2025-00264
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 18, 2025
    Manufacturer
    WICKIMED
    Product Code
    GEI
    UDI-DI
    20845854061210
    PMA / PMN Number
    K230547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D3 UPDATED MANUFACTURER NARRATIVE: EXAMINATION OF THE RETURNED USED DEVICE PLPUL2020 FOUND THAT NO BROKEN PIECE WAS FOUND IN THE DEVICE. TRIED FITTING AN ELECTRODE INTO THE DEVICE AND THE ELECTRODE FIT AS INTENDED. NO FAULT WAS FOUND WITH THIS DEVICE. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF 2 DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUESTED FROM THE MANUFACTURER, AND NO INDICATION OF ABNORMALITIES WAS COMMUNICATED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: IF NECESSARY TO REMOVE BLADE, UNPLUG THE PENCIL. ENSURE THAT CAM IS IN THE LOCK POSITION. USE A SURGICAL CLAMP AND PULL BLADE FORWARD. REPLACE WITH BLADE OF CHOICE. CONFIRM THAT BLADE IS COMPLETELY INSERTED AND SECURE BEFORE ACTIVATING PENCIL. NEVER FORCE THE BLADE INTO THE PENCIL. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2025 AND ¿¿USING THE ULTRA AND THE PIECE INSIDE THE ULTRA BROKE OFF WHEN SWAPPING OUT THE ELECTRODE¿" THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    UPDATE RECEIVED ON 5DEC25: THE PROCEDURE WAS A MULTILEVEL POSTERIOR SPINE FUSION. THE DEVICE DID NOT FRAGMENT. "A COMPONENT FAILED. THE TIP WAS SWAPPED OUT BEFORE THE PROCEDURE BEGAN AND THEN 60 LATER THE HOUSING FOR THE TIPS CRACKED DURING THE PROCEDURE AND THIS CAUSED THE TIP TO FEEL LESS SECURE AND WOBBLE WITHING THE HOUSING. THIS WAS NOTICEABLE TO THE SURGEON AND HE FELT IT UNSAFE FOR THE CONTINUE WITH THE BROKEN DEVICE." THE PROCEDURE WAS COMPLETED WITH A 5 MINUTE DELAY. THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2025 AND ¿¿USING THE ULTRA AND THE PIECE INSIDE THE ULTRA BROKE OFF WHEN SWAPPING OUT THE ELECTRODE¿" THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783422 PLUMEPEN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI WICKIMED WM20250518 20845854061210

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown