BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORA-50 RF GENERATOR

    MDR report key: 242497 · Received September 22, 1999

    Report

    Report Number
    2953127-1999-00007
    Event Type
    Other
    Date Received
    September 22, 1999
    Date of Event
    August 23, 1999
    Report Date
    September 22, 1999
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RETURN ELECTRODE PAD CAME LOOSE DURING AN ELECTROSURGICAL PROCEDURE, AND RESULTED IN A BURN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORA-50 RF GENERATOR ELECTROSURGICAL UNIT GEI ORATEC INTERVENTIONS, INC. ORA-50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other