BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERSCOPE "URF-P5", SET E

    MDR report key: 12960511 · Received December 8, 2021

    Report

    Report Number
    8010047-2021-15748
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Report Date
    June 24, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    UDI-DI
    04953170340307
    PMA / PMN Number
    K912120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    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, IT IS LIKELY THAT THE ISSUE OCCURRED DUE TO IMPROPER HANDLING AND/OR REPROCESSING. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. HANDLING AND REPROCESSING IS COVERED IN THE INSTRUCTIONS FOR USE: IFU. DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, AND CONTROL SECTION WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, SUCH AS BURNS, BLEEDING, AND/OR PERFORATION. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. ·DO NOT PRESS THE INSERTION TUBE AGAINST THE SHEATH GRIP FORCEFULLY. THE INSERTION TUBE MAY BECOME DAMAGED. ·IF NECESSARY, APPLY A MEDICAL GRADE, WATER-SOLUBLE LUBRICANT TO THE ENDOSCOPE¿S INSERTION TUBE. ·COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS : DETERGENT SOLUTION : USE A MEDICAL-GRADE, LOW-FOAMING DETERGENT, NEUTRAL PH DETERGENT OR ENZYMATIC DETERGENT AND FOLLOW THE MANUFACTURER¿S DILUTION AND TEMPERATURE RECOMMENDATIONS. CONTACT OLYMPUS FOR THE NAMES OF SPECIFIC BRANDS THAT HAVE BEEN TESTED FOR COMPATIBILITY WITH THE ENDOSCOPE. DO NOT REUSE DETERGENT SOLUTIONS. ·THE STORAGE CABINET MUST BE CLEAN, DRY, WELL VENTILATED AND MAINTAINED AT AMBIENT TEMPERATURE. STORING THE ENDOSCOPE IN DIRECT SUNLIGHT, AT HIGH TEMPERATURES, IN HIGH HUMIDITY OR EXPOSED TO OZONE, X-RAYS AND/OR ULTRAVIOLET-RAYS MAY DAMAGE THE ENDOSCOPE OR PRESENT AN INFECTION CONTROL RISK. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENON, AND ALSO FOUND THAT THIS PHENOMENON WAS ATTRIBUTED TO THE DETERIORATION. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE HAD BEEN PARTIALLY PEELED OFF MORE THAN 4MM DURING THE INCOMING INSPECTION FOR THE REPAIR OF THE SUBJECT DEVICE AT OLYMPUS (B)(4). THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861727 FIBERSCOPE "URF-P5", SET E URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P5 04953170340307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown