BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE, SINGLE USE

    MDR report key: 3488706 · Received October 24, 2013

    Report

    Report Number
    3488706
    Event Type
    Malfunction
    Date Received
    October 24, 2013
    Date of Event
    October 18, 2013
    Report Date
    October 24, 2013
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE END OF THE DEVICE WAS LOOSE ON THE TVR CONNECTOR CORD AND THEREFORE COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547137 CABLE, SINGLE USE ELECTROSURGICAL GEI OLSEN MEDICAL * 024285

    Patients

    Seq Age Sex Outcome Treatment
    1 *