BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 9222532 · Received October 23, 2019

    Report

    Report Number
    8010047-2019-03666
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Report Date
    November 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K181451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS (B)(4) BEFORE THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). ACCORDING TO THE INVESTIGATION BY OFR, IT WAS FOUND THAT TWO CABLE SUPPORTS IN THE BENDING SECTION WERE PEELED OFF. THE SUBJECT DEVICE HAS BEEN RETURNED TO OMSC FOR EVALUATION NOW. HOWEVER, THE EVALUATION IS IN PROGRESS AT THIS TIME. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE SUBJECT DEVICE AND CONCLUDED AS THE FOLLOWING. ABOUT THE BLACK DOTS DISPLAYED ON THE ENDOSCOPIC IMAGE: OMSC CONSIDERED THAT THE STRESS WAS APPLIED TO THE IMAGE GUIDE BUNDLE AND THE IMAGE GUIDE WAS BROKEN. ABOUT THE CAUSE OF CABLE SUPPORT PEEL-OFF: DURING THE PROCEDURE TO ACCESS THE INFERIOR CALYX OF KIDNEY, THE ANGLE OPERATION WAS FORCIBLY PERFORMED WITH THE DISTAL END FIXED INSIDE THE KIDNEY. AS A RESULT, THE CABLE SUPPORT WAS STRESSED AND PEELED OFF FROM THE BENDING SECTION. THE DEVICE HISTORY RECORD INDICATES THAT THE SUBJECT DEVICE HAS BEEN SHIPPED IN CONFORMITY TO THE SPECIFICATIONS. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    AT AN UNSPECIFIED TIMING, MORE THAN 20 BLACK DOTS WERE DISPLAYED ON THE ENDOSCOPIC IMAGE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024838 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P7

    Patients

    Seq Age Sex Outcome Treatment
    1