BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATION

    MDR report key: 17170007 · Received June 21, 2023

    Report

    Report Number
    17170007
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 8, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE COBLATOR HANDPIECE DIDN'T WORK. WE PLUGGED IT IN, THE MACHINE WOULDN'T REGISTER THAT IT WAS PLUGGED IN. WE TOOK IT OUT OF SERVICE AND TRIED A DIFFERENT HANDPIECE THAT WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999625 COBLATION ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI SMITH & NEPHEW, INC. EICA5872-01 2114112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown