BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 16733168 · Received April 13, 2023

    Report

    Report Number
    3002808148-2023-03683
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 16, 2023
    Report Date
    August 3, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170411199
    PMA / PMN Number
    K221683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, SINCE THE USER DID NOT SEND THE DEVICE TO OLYMPUS, DETAILED INFORMATION ON THE SUGGESTED PHENOMENON COULD NOT BE OBTAINED. A SPECIFIC CAUSE OF THE PHENOMENON "DELAYED PROCEDURE DUE TO INTERMITTENT BLANK SCREEN/SCOPE COMMUNICATION ERROR AT CONNECTING THE DEVICE" COULD NOT BE IDENTIFIED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "INSTRUCTIONS: VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2/VA2/V2R CHAPTER 3 PREPARATION AND INSPECTION". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS THAT DURING A CYSTOSCOPY, THE VIDEO SYSTEM CENTER HAD AN INTERMITTENT BLANK SCREEN AS WELL AS AN INTERMITTENT SCOPE CONNECTION ERROR. DUE TO THESE ISSUES, THERE WAS A ONE HOUR DELAY IN THE PROCEDURE. IT WAS UNKNOWN IF ADDITIONAL TREATMENT WAS REQUIRED, BUT THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED MULTIPLE TIMES BUT WAS NOT RECEIVED. THIS EVENT INCLUDED 3 DEVICES. PATIENT IDENTIFIER (B)(6) IS FOR THE VIDEO SYSTEM CENTER. PATIENT IDENTIFIER (B)(6) IS FOR A CYSTO-NEPHRO VIDEOSCOPE. PATIENT IDENTIFIER (B)(6) IS FOR A VISERA CYSTO-NEPHRO VIDEOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244806 VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-V2 04953170411199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CYSTO-NEPHRO VIDEOSCOPE - SERIAL UNKNOWN| VIDEO SYSTEM CENTER ¿ SERIAL (B)(6).