BEUDAMED
    FDA Adverse Event Summary report: N

    PROBE, DOPPLER

    MDR report key: 5644865 · Received May 10, 2016

    Report

    Report Number
    2921578-2016-00008
    Date Received
    May 10, 2016
    Date of Event
    January 26, 2016
    Report Date
    May 10, 2016
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT IDENTIFIED MIZUHO OSI AS THE MANUFACTURER, BUT MIZUHO OSI DOES NOT PRODUCE DOPPLER PROBES.

    Description of Event or Problem · 1

    THE DOPPLER PROBE WAS NOT WORKING DURING THE SURGICAL PROCEDURE. NO SOUND WAS HEARD. NO INJURY OCCURRED TO THE PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ENDOSCOPIC TRANSSPHENOIDAL HYPOPHYSECTOMY DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300894 PROBE, DOPPLER JAF MIZUHO ORTHOPEDIC SYSTEMS, INC. 07-150-10

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other