BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATION

    MDR report key: 21630839 · Received March 18, 2025

    Report

    Report Number
    21630839
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 11, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PROCISE MAX COBLATION WAND, WHEN INITIALLY PLUGGED IN FOR THE CASE, THREW AN ERROR CODE "WAND EXPIRED." THE WAND ACCORDING TO THE PACKAGE EXPIRATION DATE IS NOT EXPIRED (EXP: 02-21-2027). THESE WANDS CAN ONLY BE PLUGGED IN ONE TIME. IF UNPLUGGED AND THEN PLUGGED IN AGAIN, THEY WILL THROW THE "WAND EXPIRED" ERROR, THIS WAS NOT THE CASE TODAY, IT WAS ONLY PLUGGED IN ONCE. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, COBLATION (PER SITE REPORTER). WAITING FOR THE VENDOR TO CONDUCT THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804397 COBLATION ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI SMITH & NEPHEW, INC. EICA8898-01 2145411

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female