BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10122317 · Received June 5, 2020

    Report

    Report Number
    8010047-2020-03140
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 5, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170339752
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OMSC BUT WERE RETURNED TO OLYMPUS (B)(4) PTY LTD. (OAZ) FOR EVALUATION. IN THE EVALUATION OF OAZ THE FOLLOWING WAS CONFIRMED; -BENDING SECTION IS DEFORMED. THE DISTAL END CAP HAS DENTS AND SCRATCHES. BENDING ANGLE DOES NOT MEET SPECIFICATION. BENDING RUBBER ADHESIVE IS DETACHED. 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 FOR THREE TIMES BY THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES. THE USER REQUESTED TO CHANGE THE CHANNELS AS REPAIR. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF MICROBES. 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
    585980 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-2TH180 04953170339752

    Patients

    Seq Age Sex Outcome Treatment
    1