BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 6337470 · Received February 16, 2017

    Report

    Report Number
    2951238-2017-00084
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Report Date
    March 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    PK072957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE REPORTED DEVICE DAMAGE. THE CABLE SUPPORT ON THE BENDING SECTION SKELETON AREA WAS PROTRUDING OUT OF THE BENDING SECTION COVER. THE BENDING SECTION COVER WAS REMOVED AND FOUND THE CABLE SUPPORT FROM THE BENDING SECTION SKELETON BROKEN AND LIFTING. THE SCOPE WAS SERVICED AND RETURNED TO THE USER FACILITY. THIS TYPE OF BENDING SECTION DAMAGE IS ATTRIBUTED TO EXCESSIVE FORCE. THE INSTRUCTION MANUAL FOR USE 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 PREPARATION FOR USE, IT WAS NOTED THAT THE SCOPE¿S BENDING SECTION RUBBER WAS COMING OFF. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED DEVICE. THE INTENDED UNSPECIFIED PROCEDURE WAS COMPLETED USING A DIFFERENT SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120360 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2R N/A

    Patients

    Seq Age Sex Outcome Treatment
    1