BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17729075 · Received September 12, 2023

    Report

    Report Number
    9610595-2023-13165
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 9, 2023
    Report Date
    October 4, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE FOREIGN MATERIAL WAS INSUFFICIENT CLEANING. IDENTIFICATION OF THE MATERIAL COULD NOT BE DETERMINED. THE DEVICE WAS REPROCESSED ACCORDING TO THE RECOMMENDATION OF THE RKI (ROBERT KOCH-INSTITUT). BEFORE AND AFTER BRUSHING THE CHANNELS DURING PRE CLEANING WITH A DETERGENT, THE DEVICE WAS FLUSHED ADDITIONAL WITH A FLUSHING DEVICE (EPW 100/STEELCO). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMERS ALLEGATION WAS NOT CONFIRMED. IT WAS NOTED THAT THAT THE INSULATION RESISTANCE VALUE AT THE DISTAL END DID NOT MEET STANDARD VALUE DUE TO ADHESIVE PEELING ON THE BENDING SECTION RUBBER. THE IMAGE HAD A PARTIAL DARK AREA DUE TO CHIP ON THE OBJECTIVE LENS. THE BENDING ANGLE IN THE UP DIRECTION EXCEEDED STANDARD VALUE DUE TO DAMAGE ON THE BENDING TUBE AND THE OBJECTIVE LENS HAD A SCRATCH. THE LIGHT GUIDE LENS HAD A CRACK. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS, THAT THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE BOWDEN CABLES WERE LOOSE. THE ISSUE WAS FOUND DURING A PROCEDURE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE AIR/WATER TUBE, AIR/WATER CYLINDER AND SCOPE CYLINDER HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231408 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown