BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 6363214 · Received February 27, 2017

    Report

    Report Number
    2951238-2017-00130
    Event Type
    Malfunction
    Date Received
    February 27, 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
    MN, US
    Reporter Occupation
    OTHER

    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 WAS UNABLE TO CONFIRM THE REPORTED DEVICE DAMAGE. A VISUAL INSPECTION FOUND THE DISTAL END IN GOOD CONDITION; HOWEVER, IT WAS NOTED THAT A METAL PIN WAS FOUND PROTRUDING THROUGH THE BENDING SECTION COVER APPROXIMATELY 7MM FROM THE PROXIMAL END OF THE BENDING SECTION COVER GLUE. IN ADDITION, THE GLUE ON THE DISTAL END AND PROXIMAL END WAS FOUND WITH SCRATCHES AND SCRAPES. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THE CAUSE OF THE BROKEN SKELETON COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THIS TYPE OF BENDING SECTION DAMAGE IS LIKELY 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 AN UNSPECIFIED PROCEDURE, THE DISTAL END OF THE SCOPE WAS KINKED/DAMAGED WITH SHARP EDGES. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145364 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2R N/A

    Patients

    Seq Age Sex Outcome Treatment
    1