BEUDAMED
    FDA Adverse Event Summary report: N

    ICC

    MDR report key: 4212601 · Received October 16, 2014

    Report

    Report Number
    4212601
    Date Received
    October 16, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ERBE USA, INC
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO TECH WAS REMOVING AN ERBE CIRCUMFERENTIAL PROBE FROM SCOPE PORT. THE TECH COILED THE PROBE TO DISCONNECT FROM THE MACHINE, AT THIS TIME SHE HEARD A BEEP AND FELT A CURRENT GO UP HER LEFT ARM TO HER CHEST. MD STATED HE STEPPED ON THE WRONG PEDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659778 ICC ELECTROSURGICAL GEI ERBE USA, INC 200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *