BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 11691582 · Received April 20, 2021

    Report

    Report Number
    8010047-2021-05125
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    June 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K172298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO OLYMPUS KOREA CO., LTD. (OKR) FOR EVALUATION. OMSC CONFIRMED THE FOLLOWING FROM THE PHOTOS SENT BY OKR. THERE WAS A LEAKAGE AT THE EYEPIECE. THE INSIDE OF THE DEVICE WAS CORRODED. BLACK SPOTS AND BLACK SHADOWS WERE DISPLAYED ON THE ENDOSCOPIC IMAGE. THIS MAY HAVE BEEN CAUSED BY DAMAGE TO THE IMAGE GUIDE BUNDLE AND THE LIGHT GUIDE BUNDLE, BASED ON THE SIGNIFICANT CORROSION INSIDE THE DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OMSC. HOWEVER, THE REPORTED EVENT MAY HAVE CAUSED BY THE CORROSION OF THE ANGLE WIRE DUE TO THE WATER INVASION INSIDE THE DEVICE, BASED ON THE INFORMATION BELOW. THE PAST SIMILAR CASES HAVE BEEN ATTRIBUTED TO INCORRECT LASER IRRADIATION. HOWEVER, THE INSPECTION OF THE DEVICE BY OKR DID NOT REVEAL ANY EVIDENCE OF LASER IRRADIATION OR LEAKAGES IN THE INSTRUMENT CHANNEL. SINCE THERE WAS A LEAKAGE IN THE EYEPIECE AND THE INSIDE OF THE DEVICE WAS CORRODED, THE ANGLE WIRE MAY HAVE CORRODED DUE TO THE LEAKAGE IN THE EYEPIECE, LEADING TO BREAKAGE. FROM THE PHOTOS SENT BY OKR, THE LEAKED PART IS THE SLIDING PART, AND THE DEGREE OF LEAKAGE IS NOT SIGNIFICANT, SO THERE IS A POSSIBILITY THAT THE WATERTIGHT PART HAS DETERIORATED DUE TO REPEATED USE. IN ADDITION, IT IS ALSO POSSIBLE THAT THE DEVICE WAS USED IN A STATE THAT THE WATER LEAKAGE TEST WAS NOT PROPERLY PERFORMED AT THE FACILITY, SINCE THE INSIDE THE DEVICE IS SIGNIFICANTLY CORRODED. THE INSTRUCTION MANUAL PROVIDES THE PRE-USE INSPECTION OF ANGLE OPERATION AND WARNINGS ABOUT PERFORMING A LEAKAGE TEST. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INSPECTION BY (B)(4) ALSO FOUND FOLLOWINGS; THE DISTAL END WAS CORRODED DUE TO DETERIORATION DUE TO REPROCESSING. DIRT HAD ADHERED TO THE CONTROL BODY DUE TO THE CHEMICAL STRESS OF THE REPROCESS. THE FORCEPS CHANNEL PORT WAS CORRODED DUE TO THE CHEMICAL STRESS OF THE REPROCESS. THE EYEPIECE WAS DEFORMED BY PHYSICAL STRESS. A DEFECT IN THE LIGHT GUIDE BUNDLE CAUSED DOTS TO APPEAR ON THE ENDOSCOPIC IMAGE. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE ANGLE OF THE BENDING SECTION MALFUNCTIONED BECAUSE THE ANGLE WIRE WAS CUT. THE BENDING SECTION WAS FIXED AND THE ANGLE COULD NOT BE MANIPULATED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591574 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P6

    Patients

    Seq Age Sex Outcome Treatment
    1