BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY OLSEN

    MDR report key: 7302163 · Received February 28, 2018

    Report

    Report Number
    7302163
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    December 18, 2017
    Report Date
    February 23, 2018
    Manufacturer
    OLSEN MEDICAL, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS UTILIZING ELECTRO CAUTERY BLADE AND WHEN USING IT FOR ABOUT 10 MIN. THE SHEATH AROUND THE END FELL APART. NO FRAGMENTS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145903 SYMMETRY OLSEN ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI OLSEN MEDICAL, LLC 30-0014 027133

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR