BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND 2001 LEOPARD

    MDR report key: 1723101 · Received June 10, 2010

    Report

    Report Number
    MW5016306
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 9, 2010
    Manufacturer
    B.K. MEDICAL SYSTEMS, INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR PROSTATE BRACHYTHERAPY. BRACHYTHERAPY PROBE CHECKED PRIOR TO PROCEDURE BY PHYSICIAN. DURING THE TRANSRECTAL ULTRASOUND PORTION OF THE PROCEDURE, SAGITTAL VIEWS OF THE PROSTATE WERE NOT VISIBLE. TROUBLESHOOTING PERFORMED; CLINICAL ENGINEERING CONTACTED. BECAUSE THE ISSUE COULD NOT BE CORRECTED, THE PROCEDURE WAS TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND 2001 LEOPARD BRACHYTHERAPY PROBE ITX B.K. MEDICAL SYSTEMS, INC. 2001LEOPARD

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR