BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 16872823 · Received May 4, 2023

    Report

    Report Number
    3002808148-2023-04561
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Report Date
    May 30, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170286964
    PMA / PMN Number
    K032092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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 FORCEPS PLUG CAP WAS SCRAPED. ADDITIONALLY, THE FORCEPS CHANNEL PORT WAS DETACHED; DUE TO PHYSICAL STRESS. DUE TO THE SHAVED FORCEPS CHANNEL PORT; WATER TIGHTNESS WAS LOST. UPON FURTHER INSPECTION, IT WAS OBSERVED, THAT THE ADHESIVE ON THE BENDING SECTION COVER HAD A CHIP; DUE TO CHEMICAL OR PHYSICAL STRESS. IT WAS ALSO OBSERVED, THAT THE BENDING ANGLE IN THE UP DIRECTION DID NOT MEET THE STANDARD VALUE; DUE TO WEAR OF THE ANGLE WIRE. IT WAS OBSERVED, THAT THE VENTING CONNECTOR UNDER THE GRIP HAD CORROSION; DUE TO DETERIORATION OR DUE TO CHEMICAL STRESS. LASTLY, SCRATCHES WERE OBSERVED ON THE FOLLOWING UNIT COMPONENTS, DUE TO PHYSICAL STRESS CAUSED BY A HANDLING PROBLEM: CONNECTING TUBE, EYEPIECE, DIOPTER RING, CONTROL UNIT, GRIP, UP-DOWN PLATE, LOCK ENGAGEMENT LEVER AND ON THE ANGULATION LEVER. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    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. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED; HOWEVER, THE EVENT LIKELY OCCURRED DUE TO MISHANDLING AT THE FACILITY. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "DO NOT BEND OR HIT THE DISTAL END, INSERTION TUBE, BENDING SECTION, OPERATION SECTION, LIGHT GUIDE, MINIATURE LIGHT SOURCE, OR RECHARGEABLE MINIATURE LIGHT SOURCE OF THE ENDOSCOPE WITH STRONG FORCE IN ORDER TO PREVENT DEVICE FAILURE, DAMAGE, OR PARTS FROM FALLING OFF. , DO NOT PULL, TWIST OR DROP." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE OES CYSTONEPHROFIBERSCOPE HAS A BROKEN FORCEPS MOUTH. THE REPORTED ISSUE OCCURRED, DURING REPROCESSING PRIOR TO PREPARATION OF USE FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714680 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-5A 04953170286964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown