BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 11957466 · Received June 8, 2021

    Report

    Report Number
    8010047-2021-07229
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 6, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170411298
    PMA / PMN Number
    K062049
    Removal / Correction Number
    CAPA-200413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO REPORT CORRECTED INFORMATION. CORRECTED DATA IS REPORTED IN SERIAL NUMBER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO REPORT INVESTIGATION FINDINGS. DEVICE HISTORY RECORD (DHR)/SERVICE HISTORY REVIEW: A DHR REVIEW HAS BEEN PERFORMED FOR THIS PRODUCT AND DETERMINED THAT THERE WERE NO NONCONFORMANCE'S DURING THE MANUFACTURING PROCESS OF THIS DEVICE. CONCLUSION SUMMARY: OLYMPUS COULD NOT IDENTIFY THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT. [OBSERVATIONS] WE CONFIRMED THE FOLLOWING: WE CONFIRMED THAT THIS CASE WAS ABOUT ¿THE BLACK FOREIGN MATERIAL FELL¿ INSIDE THE PATIENT¿S BODY. THERE WAS NO DETAILED DESCRIPTIONS OF THE FALLEN FOREIGN MATERIAL. ACCORDING TO THE DEVICE INSPECTION RESULTS, IT WAS CONFIRMED THAT THE ADHESIVE ON THE A-RUBBER WAS CRACKED, THE DISTAL END WAS DAMAGED, AND THERE WERE SCRATCHES ON THE LENS. IT COULD NOT BE DETERMINED WHETHER THE DAMAGE WAS CAUSED BY STRESS OR HANDLING. AS A RESULT OF CHECKING THE MANUFACTURING RECORD, IT WAS DETERMINED THE SUBJECT DEVICE WAS SHIPPED AS A GOOD PRODUCT (NO DESIGN OR SAFETY NON-CONFORMITIES) IT WAS UNCERTAIN IF THERE WAS A RELEVANCE BETWEEN THE FALLEN MATERIAL AND EACH PART OF THE DAMAGED SCOPE. STERRAD STERILIZATION WAS ADOPTED IN THE RE-PROCESSING OF THE DEVICE, BUT IT WAS UNCERTAIN IF THERE WAS A RELEVANCE TO THE REPORTED EVENT OR NOT. FROM THE ABOVE, IT IS UNCLEAR WHETHER THE BLACK FOREIGN MATTER SEEN WAS DUE TO THE DAMAGE FOUND ON INSPECTION, OR WHETHER IT IS CAUSED BY INSUFFICIENT STERILIZATION FROM THE STERRAD AUTOMATED SCOPE REPROCESSOR. DUE TO THESE FACTORS, THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION PER CAPA-200413. BASED ON THE RESULTS OF THE FURTHER INVESTIGATION, THE SUBJECT DEVICE (CYF-VHR SN: (B)(6)) WAS NOT USED ON A PATIENT, NOR RELATED TO ANY PATIENT EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER'S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3002808148.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. PHYSICAL EVALUATION OF THE COMPLAINT DEVICE REVEALS: THE SCOPE PASSED THE WATER DUNK TEST. THERE WERE MINOR SCRATCHES ON THE PLASTIC COVER. IT WAS CONFIRMED, THE RUBBER GLUE WAS CRACKED/PEELING EXPOSING THREAD. THE OB LENS GLUE WAS MISSING. THE LG LENS HAD MINOR SCRATCHES. ALL REQUIRED REPAIRS WERE COMPLETED AND THE DEVICE WAS SHIPPED BACK TO THE CUSTOMER MEETING SAFETY SPECIFICATIONS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT IS REPORTED IN MW5101053, AFTER REPROCESSING A CYSTO-NEPHRO VIDEOSCOPE, BLACK SPECKS WERE NOTED. THERE IS NO REPORTED PATIENT CONTACT/IMPACT RELATED TO THIS OCCURRENCE. IN MW5101053, THIS FACILITY REPORTS 6 CASES. REPORT WITH PATIENT IDENTIFIER (B)(6) REPORTS CASE 1 OF 6 REPORT WITH PATIENT IDENTIFIER (B)(6) REPORTS CASE 2 OF 6 REPORT WITH PATIENT IDENTIFIER (B)(6) REPORTS CASE 3 OF 6 REPORT WITH PATIENT IDENTIFIER (B)(6) REPORTS CASE 4 OF 6 REPORT WITH PATIENT IDENTIFIER (B)(6) REPORTS CASE 5 OF 6 REPORT WITH PATIENT IDENTIFIER (B)(6) REPORTS CASE 6 OF 6

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856442 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-VHR 04953170411298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown