BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 8643411 · Received May 27, 2019

    Report

    Report Number
    8010047-2019-02022
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 16, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K172298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS INDIA (OMSI). THE FOLLOWING RESULTS WERE OBTAINED BY THE DEVICE CONFIRMATION BY OMSI. MULTIPLE BLACK DOTS ON ENDOSCOPIC IMAGE. BENDING SECTION BROKEN AND CORRODED. NO MAJOR DENT FOUND ON INSERTION TUBE OR DISTAL END. NO REMARKABLE DENT OR HITTING MARK ON THE WHOLE DEVICE. THE REPORTED EVENT, THE BLACK DOTS ON ENDOSCOPIC IMAGE, WAS CAUSED BY BROKEN IMAGE GUIDE FIBER BUNDLE RUNNING INSIDE THE BENDING SECTION ALTHOUGH THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, EXCESSIVE FORCE LIKELY BROKE THE BENDING SECTION AND THE IMAGE GUIDE FIBER BUNDLE AS DAMAGES WERE NOTED IN THE DEVICE. THE FOLLOWING ARE EXAMPLES OF EXCESSIVE FORCE WHICH COULD APPLY TO THE DEVICE. FORCIBLY INSERTING THE DEVICE TO A PATIENT ANGULATING THE BENDING SECTION. ATTEMPTING TO ANGULATE THE BENDING SECTION IN A DIRECTION THAT THE DEVICE CANNOT BEND.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT BLACK DOTS APPEARED ON THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE DURING A THERAPEUTIC PROCEDURE (RETROGRADE INTRARENAL SURGERY). THE USER FACILITY REPLACED THE DEVICE WITH SIMILAR DEVICE AND COMPLETED THE PROCEDURE BY PERCUTANEOUS NEPHROLITHOTOMY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437655 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P6R

    Patients

    Seq Age Sex Outcome Treatment
    1