BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR RESECTOSCOPE

    MDR report key: 6084913 · Received November 8, 2016

    Report

    Report Number
    6084913
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 4, 2016
    Manufacturer
    OLYMPUS CORPORATION OF THE AMERICAS
    Product Code
    FBO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN OPTED FOR TRANSURETHRAL RESECTION OF PROSTATE (TURP) DUE TO ISSUES OF VISUALIZATION OF THE GREEN LIGHT LASER. THE PHYSICIAN PROCEEDED WITH OLYMPUS CONTINUOUS FLOW RESECTOSCOPE SET. IT WAS NOTED THAT THE LOOP WAS NOT CUTTING CORRECTLY AND IT WAS NOT RETRACTING COMPLETELY. DURING THE RESECTION, THE PHYSICIAN NOTED A FOREIGN BODY IN THE BLADDER. UPON EXAMINATION IT WAS THE WHITE PLASTIC TIP OF THE RESECTOSCOPE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PLASTIC TIP THAT WAS IN THE BLADDER BUT DUE TO POOR VISUALIZATION POST-TURP, COULD NOT RETRIEVE IT. PATIENT CAN CURRENTLY URINATE AND WANTS TO LEAVE IT IN UNLESS A PROBLEM OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737573 BIPOLAR RESECTOSCOPE CYSTOURETHROSCOPE FBO OLYMPUS CORPORATION OF THE AMERICAS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR