BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEOSCOPE "URF-V"

    MDR report key: 10972510 · Received December 8, 2020

    Report

    Report Number
    8010047-2020-10067
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Report Date
    March 4, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K072957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. NO DEVIATION IN THE REPROCESSING PROCEDURE FROM THE IFU WAS DETECTED. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION.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 MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. AN UNSPECIFIED MICROBE (2 CFU/WASHING) PANTOEA SEPTICA (8 CFU/MEMBRANE FILTRATION) MORAXELLA OSLOENSIS (6 CFU/2 MEMBRANE FILTRATION) THE DEVICE HAD BEEN REPROCESSED A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, INNOVA E4 USING GLUTARAL. THE SERVICE DEPARTMENT OF THE SERVICE DEPARTMENT OF OLYMPUS EUROPE SE & CO. KG (OEKG) CHECKED THE SUBJECT DEVICE AND FOUND THE FOLLOWING. THE LEAKAGE FROM THE INSERTION TUBE LOCK/FREE KNOB THE DAMAGE OF THE BENDING SECTION RUBBER ADHESIVE THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437561 VIDEOSCOPE "URF-V" URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V

    Patients

    Seq Age Sex Outcome Treatment
    1