BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 15124299 · Received July 28, 2022

    Report

    Report Number
    3002808148-2022-00422
    Event Type
    Injury
    Date Received
    July 28, 2022
    Report Date
    December 17, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170411274
    PMA / PMN Number
    K062049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    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. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CUSTOMER PERFORMED A CULTURE TEST ON THE SCOPES (CYF-VA2 AND CYF-VHA), BUT BACTERIAL GROWTH WAS NOT CONFIRMED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO CONTACT THEM.¿ THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO B5, D4, D8, G2 AND H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTIONS TO THE PREVIOUS SUBMISSIONS. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE FINDINGS ARE AS FOLLOWS: AFTER CHECKING THE APPEARANCE, NO ABNORMALITIES WERE FOUND IN PLACES THAT COULD BE VISUALLY CONFIRMED. NO ADHERING MATTER COULD BE CONFIRMED ON THE DEVICE. IN ADDITION, AFTER CONNECTING AND OPERATING ACCORDING TO THE INSTRUCTION MANUAL, NO ABNORMALITY WAS FOUND. ALSO, A CORRECTION HAS BEEN MADE TO D9, H3, AND H6 FROM THE PREVIOUS SUBMISSIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OVER THE LAST 1-2 MONTHS, A CLUSTER OF FIVE PATIENTS HAVE BEEN INFECTED WITH URINARY TRACT INFECTIONS AFTER ENDOSCOPY USING ONE OF TWO CYSTOSCOPES THAT WERE PROCESSED IN AN OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1 OF 5 -SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2 OF 5 -SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3 OF 5 -SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4 OF 5- SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5 OF 5- SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SECOND SCOPE PROCESSED IN THE OER-S (CYF-VA2) (POTENTIAL FOR CROSS CONTAMINATION). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 1 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 2 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 3 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 4 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 5 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS POTENTIAL CROSS CONTAMINATION OF CYF-VA2 BY OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE MAJ-891 USED BY THE ORE-S FOR THE REPROCESSOR. MORE THAN A YEAR AGO, THERE WAS SOMETHING LIKE GREEN ALGAE GROWING ON THE WATER FILTER. IN VIEW OF THIS, THE FACILITY IS CONCERNED ABOUT INFECTION CAUSED BY OER-S. AT THAT TIME, THE FACILITY STAFF DID NOT FIND ANY ABNORMALITIES AFTER THE RESPONSE, SO THE PROCESS WAS COMPLETED WITHOUT ANY PROBLEMS, AND THERE WAS NO PROBLEM WITH THE FREQUENCY OF FILTER REPLACEMENT AT THE FACILITY NOTED. MICROBIOLOGICAL INVESTIGATION OF THE REPORTED REPROCESSOR INDICATES THE OER-S IS NOT THE SOURCE OF INFECTION IN THE REPORTED PATIENTS. ADDITIONAL DETAILS REGARDING THE PATIENTS AND REPORTED EVENTS HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS RECEIVED: ALL FIVE PATIENTS EXPERIENCED FEVER, CHILLS, PAIN WHEN URINATING, AND FREQUENT URINATION. THE PATIENTS WERE PRESCRIBED ANTIBIOTICS AT THE TIME OF THE ENDOSCOPY. ALTHOUGH THE PATIENTS WERE HOSPITALIZED FOR FEVER, UPON RE-EXAMINATION, THE PATIENTS RECOVERED AND REPORTED TO BE IN GOOD CONDITION. THE PHYSICIAN SUSPECTS THE POSSIBILITY OF OLYMPIC EQUIPMENT CONTRIBUTING TO THE INFECTIONS DUE TO THE LARGE NUMBER OF PATIENTS RETURNING WITH ALMOST IDENTICAL SYMPTOMS APPROXIMATELY TEN DAYS AFTER EACH ENDOSCOPIC PROCEDURE. THERE WERE NO ADDITIONAL INSTRUMENTS USED DURING THE PROCEDURES. ALTHOUGH, ADDITIONAL INFORMATION REGARDING THE PATIENTS AND THE OCCURRENCE OF DISEASE WERE REQUESTED, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332866 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-VHA 04953170411274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other