BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGI TRANSDUCER COVER

    MDR report key: 5031076 · Received August 26, 2015

    Report

    Report Number
    5031076
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 22, 2015
    Report Date
    August 10, 2015
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE SURGICAL CASE WAS FINISHED, STAFF DISCOVERED THERE WAS A HOLE IN THE NEOPROBE COVER BECAUSE THE NEOPROBE WAS BLOODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563643 SURGI TRANSDUCER COVER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX CIVCO MEDICAL INSTRUMENTS CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NO