BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 12072983 · Received June 27, 2021

    Report

    Report Number
    8010047-2021-08022
    Event Type
    Malfunction
    Date Received
    June 27, 2021
    Report Date
    September 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K172246
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OEKG. OEKG CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENON. 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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON (THE BROKEN INTERNAL METAL PART HAD BEEN STICKING OUT FROM THE INSIDE OF BENDING SECTION COVER) COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM (B)(4) AND SIMILAR PAST CASES, OMSC SURMISED THAT THIS PHENOMENON WAS ATTRIBUTED TO THE EXCESSIVE FORCE BEING APPLIED TO THE BENDING SECTION DUE TO THE USER HANDLING. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED DURING THE INCOMING INSPECTION FOR REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS EUROPA SE & CO. KG (OEKG), IT WAS FOUND THAT THE BENDING SECTION COVER OF THE SUBJECT DEVICE HAD BEEN TORN AND THE BROKEN INTERNAL METAL PART HAD BEEN STICKING OUT FROM THE INSIDE OF BENDING SECTION COVER OF THE SUBJECT DEVICE, AND THE ADHESIVE OF THE BENDING SECTION RUBBER WAS DETERIORATED AND DISCOLORED WITH EXPOSING THE INNER THREADS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969793 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1