BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 11846242 · Received May 18, 2021

    Report

    Report Number
    8010047-2021-06476
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 8, 2021
    Report Date
    August 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K172246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS EUROPA SE & CO. KG (OEKG). OEKG CHECKED THE SUBJECT DEVICE AND FOUND THE FOLLOWING. - THE ADHESIVE OF THE BENDING SECTION RUBBER WAS WORN OUT. - THERE WERE CATCHES AND SHAVINGS INSIDE THE INSTRUMENT CHANNEL. OEKG REQUESTED THE FACILITY TO PROVIDE THE INFORMATION REGARDING REPROCESSING, HOWEVER THE USER FACILITY DID NOT PROVIDE AND OEKG COULD NOT OBTAIN IT. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM THE USER FACILITY AND OEKG, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING. - THERE WAS A DIFFERENCE BETWEEN THE REPROCESSING METHOD PERFORMED BY THE USER AND THE REPROCESSING METHOD RECOMMENDED BY THE INSTRUCTION MANUAL. - CONTAMINATION OCCURRED DURING THE MICROBIOLOGICAL TEST SAMPLING BY THE USER FACILITY. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4). OLYMPUS (B)(4) SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE ALL CHANNELS OF THE DEVICE. THE TESTING RESULT CLEARED THE (B)(6) GUIDELINE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. ALL CHANNELS: STAPHYLOCOCCUS A COAGULASE NEGATIVE (12 CFU/ENDOSCOPE). OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741941 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1