BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 6301218 · Received February 3, 2017

    Report

    Report Number
    2951238-2017-00056
    Event Type
    Malfunction
    Date Received
    February 3, 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
    TX, US
    Reporter Occupation
    NURSE

    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 BENDING SECTION OF THE SCOPE WAS FOUND CRACKED WITH THE SKELETON RIBS PROTRUDING THROUGH THE BENDING SECTION RUBBER NEAR THE INSERTION TUBE. THERE WAS ALSO A HOLE AND LEAK NOTED ON THE BENDING SECTION RUBBER. THE BENDING SECTION RUBBER ADHESIVE WAS ALSO FOUND CHIPPED. THE SCOPE FAILED LEAK TEST. 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 THE SCOPE FIBERS WERE FOUND EXPOSED THROUGH THE BENDING SECTION . THE SCOPE WAS NOT USED IN A PROCEDURE AT THE TIME THE DEVICE DAMAGE WAS NOTED. NO PATIENT OR USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82664 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2R N/A

    Patients

    Seq Age Sex Outcome Treatment
    1