BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 7937063 · Received October 4, 2018

    Report

    Report Number
    2951238-2018-00607
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    UDI-DI
    04953170310522
    PMA / PMN Number
    K062049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM NWB TO FAJ.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND THE BENDING SECTION COVER GLUE FROM THE DISTAL END AND INSERTION TUBE SIDE CRACKED WITH PORTIONS OF THE CEMENT MISSING/BROKEN OFF. THE MISSING/BROKEN OFF CEMENT WAS NOT RETURNED. THERE WERE SCRATCHES NOTED ON THE BENDING SECTION COVER GLUE, WHICH LIKELY CAUSE THE DAMAGE TO THE CEMENT. THE SCOPE¿S BIOPSY CHANNEL WAS INSPECTED WITH OLYMPUS TELESCOPE AND NO MISSING PARTS OR FOREIGN OBJECTS/MATERIALS WERE NOTED INSIDE THE CHANNEL. BASED ON THE REPORTED COMPLAINT THE CAUSE OF THE DAMAGE ON THE BENDING SECTION COVER CEMENT IS DUE TO MISHANDLING THE INSTRUCTION MANUAL PROVIDES WARNING WHICH STATES, ¿DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, A PIECE OF THE SCOPE¿S DISTAL TIP FELL INSIDE THE PATIENT'S BLADDER. IT IS UNKNOWN IF THE DEVICE FRAGMENT WAS RETRIEVED OR IF THE INTENDED PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773885 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-VHR 04953170310522

    Patients

    Seq Age Sex Outcome Treatment
    1