BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR WAND

    MDR report key: 23436640 · Received October 31, 2025

    Report

    Report Number
    MW5178347
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Report Date
    October 27, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    501
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TIP END MELTED OFF DURING PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/3/2025 FOR REPORT MW5178347 TO UPDATE PROCODE TO GEI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299680 COBLATOR WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SMITH & NEPHEW, INC. EICA5872-01 2184810

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown