BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS TOUCH

    MDR report key: 7394012 · Received April 3, 2018

    Report

    Report Number
    3000719969-2018-00004
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    December 1, 2017
    Report Date
    March 30, 2018
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    30841785106232
    PMA / PMN Number
    K973234
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS UTILIZING AN ELECTRO CAUTERY BLADE, WHEN USING THE DEVICE FOR APPROXIMATELY 10 MINUTES THE SHEATH AROUND THE END FELL APART. NO FRAGMENTS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234326 MIDAS TOUCH OLSEN BLADE ELECTRODE, MIDAS TOUCH GEI OLSEN MEDICAL LLC 30-0014 027133 30841785106232

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR