BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES URETERO-RENO FIBERSCOPE

    MDR report key: 11409981 · Received March 4, 2021

    Report

    Report Number
    8010047-2021-03285
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Report Date
    April 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    UDI-DI
    04953170316593
    PMA / PMN Number
    K912120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE WITHDRAWAL OF MFR REPORT #8010047-2021-03285 AND CORRECT THE INITIAL REPORT. BASED ON THE DEVICE INSPECTION RESULT PROVIDED BY OLYMPUS KOREA CO., LTD., OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) DETERMINED THAT THE BENDING SECTION OF THE DEVICE WAS NOT LOCKED WITH IT IS BENT. THEREFORE, OMSC CONCLUDED THAT THE CORRECT PHENOMENON IS INSUFFICIENT ANGULATION DUE TO THE ELONGATION OF THE ANGLE WIRE. BASED ON THE ABOVE INFORMATION, OLYMPUS RE-EVALUATED THE EVENT REPORTED IN THE INITIAL REPORT AND DETERMINED THAT THE FAILURE MODE IS NOT A MDR REPORTABLE MALFUNCTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO (B)(4) FOR EVALUATION. (B)(4) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING; THE ANGULATION FROM THE NEUTRAL POSITION WAS OUT OF SPECIFICATION DUE TO THE BROKEN ANGLE WIRE. THE BODY CONTROL UNIT AND GRIP UNIT WERE CONTAMINATED. THE INSTRUMENT CHANNEL PORT WAS CORRODED. A DOT WAS DISPLAYED ON THE ENDOSCOPE SCREEN DUE TO DAMAGE TO THE IMAGE GUIDE BUNDLE. THE FOCUS COULD NOT BE ADJUSTED WELL DUE TO THE DAMAGE OF THE DIOPTER ADJUSTMENT RING. THERE WAS A LEAKAGE AT THE BENDING SECTION RUBBER DUE TO A PINHOLE. THERE WAS A LEAKAGE AT THE CHANNEL DUE TO BREAKAGE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE BENDING SECTION KEPT ANGULATED, DUE TO THE BROKEN ANGLE WIRE CAUSING THE END TO COME APART. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305750 OES URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P5 04953170316593

    Patients

    Seq Age Sex Outcome Treatment
    1