BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 6244683 · Received January 11, 2017

    Report

    Report Number
    2951238-2017-00014
    Event Type
    Malfunction
    Date Received
    January 11, 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
    RI, 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 DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND A CRACK AT THE BENDING SECTION RIBS NEAR THE INSERTION TUBE. THE DEVICE 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.¿ AS PART OF OUR INVESTIGATION, OLYMPUS MADE MULTIPLE FOLLOW UPS WITH THE USER FACILITY BY TELEPHONE AND IN WRITING IN AN ATTEMPT TO GATHER ADDITIONAL INFORMATION ON THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE URETERO-RENO VIDEOSCOPE WAS FOUND BROKEN AT THE BENDING SECTION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25165 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2R N/A

    Patients

    Seq Age Sex Outcome Treatment
    1