BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 9213492 · Received October 21, 2019

    Report

    Report Number
    8010047-2019-03655
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    October 21, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K172298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED URF-P6 EYEPIECE SCOPE (SERIAL#(B)(4) WAS EVALUATED DUE TO ¿¿SUPPORT PIN DETACHED¿. A VISUAL INSPECTION WAS PERFORMED ON A RECEIVED CONDITION AND NOTED THAT THE BENDING SECTION COVER OF THE DEVICE WAS ALREADY REMOVED BY THE ESTIMATION GROUP AS PART OF THEIR ADVANCED DIAGNOSTICS PROCESS. DUE TO THE BENDING SECTION COVER WAS ALREADY REMOVED, IT WAS UNABLE TO DETERMINE WHETHER THE DEVICE HAD METAL PROTRUDING THROUGH THE BENDING SECTION COVER. IN ADDITION DURING THE VISUAL INSPECTION ON THE RECEIVED DEVICE, IT WAS DETERMINED THAT ONE OUT OF THE FOURTEEN SUPPORT PINS WAS PARTIALLY DAMAGED. THE PARTIALLY DAMAGED SUPPORT PIN IS BEGINNING TO RECEDE INTO THE CHANNEL ON ONE SIDE AND PRODUCING SHARP EDGES. THE SIDE OF THE SUPPORT PIN ADJACENT TO THE ONE THAT IS LIFTING WAS FOUND BENT AND WOULD LIKELY OCCUR IF EXCESSIVE FORCE WERE APPLIED DURING MANIPULATION OF THE BENDING SECTION. THE INSTRUCTION MANUAL STATES THE FOLLOWING ¿DO NOT OPERATE THE ANGULATION CONTROL LEVER WITH EXCESSIVE FORCE IN A NARROW SPACE TO THE OPPOSITE DIRECTION FROM THE BENDING SECTION DIRECTION WHILE THE DISTAL END OF THE ENDOSCOPE IS NOT MOVED. THE BENDING SECTION MAY BE DAMAGED. CHECK THE TIP POSITION OF THE ENDOSCOPE AND THE SHAPE OF THE BENDING SECTION USING FLUOROSCOPE, ETC. DO NOT INSERT THE INSERTION TUBE WITH EXCESSIVE FORCE AND TWIST.¿ THE EYEPIECE SCOPE WAS PREVIOUSLY REFURBISHED (28F) ON (B)(6) 2019. IT IS DETERMINED THAT THE MOST LIKELY CAUSE OF THE BENDING SECTION DAMAGE IS DUE TO EXCESSIVE FORCE, CAUSED BY MISHANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE A-RUBBER OF URF-P6 EYEPIECE SCOPE IS LEAKING FROM A PINHOLE. AFTER REMOVING THE A-RUBBER, IT WAS FOUND THAT ONE OF THE BENDING SUPPORT PIN IS DETACHED WHICH IS CAUSED BY AN EXCESSIVE FORCE. IMAGE HAS 1 IG BREAKAGE. THERE WAS NO REPORT OF USER INJURY AND NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009246 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-P6

    Patients

    Seq Age Sex Outcome Treatment
    1