BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 20049581 · Received August 23, 2024

    Report

    Report Number
    3002808148-2024-08054
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 31, 2024
    Report Date
    November 19, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170411182
    PMA / PMN Number
    K221690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE DEVICE IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000375. THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. ADDITIONALLY, TO PROVIDE A CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (D8) AND TO PROVIDE AN UPDATE TO FIELD (H3). THE DEVICE WAS EVALUATED BY OLYMPUS. AND THERE WERE NO REPORTABLE DEFECTS OBSERVED, THAT COULD HAVE LED TO THE REPORTED ADVERSE EVENT. 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 USER DID NOT PROVIDE ADDITIONAL INFORMATION OR THIRD-PARTY TEST RESULTS. THEREFORE, A RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE ROOT CAUSE OF THE REPORTED ADVERSE EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED, BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) IN SECTION: OES CYSTONEPHROFIBERSCOPE, OLYMPUS CYF-5, OLYMPUS CYF-5R, REPROCESSING MANUAL". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SINCE THE PHYSICIAN RECEIVED THE CYSTONEPHROFIBERSCOPE ON JULY 15, 2024, 4 PATIENT INFECTIONS OCCURRED AS THE SCOPE HAD A BROKEN FIBER AND THE SHEATH FELL OFF. THE SCOPE ALSO FAILED A LEAK TEST. THE PHYSICIAN AND HIS NURSE BELIEVED THAT THIS WAS AN ISOLATED INCIDENT AND THAT THE CLEANING PROCESS WAS VERIFIED BY THE HOSPITAL. AN OLYMPUS REPRESENTATIVE WENT OVER THE PROCESS OVER THE PHONE WITH THE NURSE AND CONFIRMED THAT THAT THE INSTRUCTIONS FOR USE FOR CLEANING THEIR SCOPES WAS FOLLOWED. THE NURSE DECLINED AN IN-SERVICE ON REPROCESSING FROM THE OLYMPUS REPRESENTATIVE, AND THEY BELIEVED THAT THE MATTER WAS CLOSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION WAS RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257235 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-5R 04953170411182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other