BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 17144814 · Received June 16, 2023

    Report

    Report Number
    3002808148-2023-06079
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 19, 2023
    Report Date
    July 20, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 G2 FIELD WAS CORRECTED BASED ON INFORMATION AVAILABLE AT THE INITIAL REPORT SUBMISSION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATES: "WARNING - DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, AND CONTROL SECTION WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, SUCH AS BURNS, BLEEDING, AND/OR PERFORATION. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS ABLE TO BE CONFIRMED. DURING THE DEVICE EVALUATION IT WAS OBSERVED THAT THE BLACK COVERING ON THE TIP WAS BLASTED OFF AND THE BENDING SECTION COVER WAS TORN/ CUT. DUE TO THE TORN BENDING SECTION COVER, THE SCOPE DID NOT PASS THE LEAK TEST. ADDITIONALLY, THE PLASTIC DISTAL END COVER INSULATION TEST WAS UNABLE TO BE PERFORMED DUE TO THE TORN BENDING SECTION COVER. LASTLY, IT WAS OBSERVED THAT THERE WAS CORROSION AROUND THE OBJECTIVE LENS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE VISERA CYSTO-NEPHRO VIDEOSCOPE BENDING SECTION COVER FELL OFF AND THE BLACK COVERING AT THE TIP WAS BLASTED OFF THE DISTAL END. THE REPORTED ISSUE OCCURRED AT REPROCESSING DURING STERILE PROCESSING. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661807 VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-V2 04953170411199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown