BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4630067 · Received March 18, 2015

    Report

    Report Number
    4630067
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 20, 2015
    Report Date
    March 18, 2015
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE DEVICE CLOGGED AND THE SURGEON WAS UNABLE TO GET THE DEVICE TO WORK AGAIN. THE DEVICE WAS EXCHANGED OUT FOR A NEW HANDPIECE. THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185748 * ELECTROSURGICAL, COAGULATION GEI ERBE USA, INC. 20150-236 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR