BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 17363968 · Received July 20, 2023

    Report

    Report Number
    3002808148-2023-07310
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 20, 2023
    Report Date
    August 17, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170411199
    PMA / PMN Number
    K221683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. IN ADDITION TO THE REPORTABLE MALFUNCTION, THE FOLLOWING WERE NOTED: THE BENDING SECTION COVER WAS TORN AND AS A RESULT, THE PLASTIC DISTAL END COVER INSULATION WAS UNABLE UNDERGO LEAK TESTING OR AN ELECTRICAL SAFETY TEST; THE BENDING SECTION HAD A BITE/DENT; THE VIDEO CABLE BUCKLES AT THE VIDEO CONNECTOR SIDE. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS NOT ACKNOWLEDGED, BUT IN THE ISSUED INFORMATION, THE FACT ¿THE PRESSURE CAP WAS NOT IN PLACE WHILE IN STERILIZATION¿ IS STIPULATED. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) SECTION WHICH STATES: VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS LTD TYPE V2 OLYMPUS LTD TYPE VA2 OLYMPUS LTD TYPE V2R CHAPTER 6 COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS 6.6 ETHYLENE OXIDE GAS STERILIZATION ¿ATTACH THE STERILIZATION CAP TO THE ENDOSCOPE BEFORE ETHYLENE OXIDE GAS STERILIZATION. IF THE STERILIZATION CAP IS NOT ATTACHED TO THE ENDOSCOPE DURING ETHYLENE OXIDE GAS STERILIZATION, THE AIR INSIDE THE ENDOSCOPE WILL EXPAND AND COULD RUPTURE THE BENDING SECTION COVER AND/OR DAMAGE THE ANGULATION MECHANISM (SEE FIGURE 6.2).)¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE PRESSURE CAP OF THE VISERA CYSTO-NEPHRO VIDEOSCOPE WAS NOT IN PLACE WHILE IN STERILIZATION AND BLEW OFF THE COATING OF THE DISTAL TIP. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024780 VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-V2 04953170411199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown