BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 16111016 · Received January 6, 2023

    Report

    Report Number
    3002808148-2023-00140
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 5, 2022
    Report Date
    January 6, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTS ARE BEING SUBMITTED ON THE SCOPE AND AIR/WATER VALVE UNIT. PLEASE REFER TO THE FOLLOWING REPORTS: PATIENT IDENTIFIER OF (B)(6) IS RELATED TO MODEL NUMBER: MAJ-1444, SERIAL NUMBER: N/A. PATIENT IDENTIFIER OF (B)(6) IS RELATED TO MODEL NUMBER: GF-UCT260, SERIAL NUMBER: (B)(4). AN OER-5 WAS USED AS THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER). THE CUSTOMER NOTED THAT BRUSHING WAS IMPLEMENTED PROPERLY DURING REPROCESSING. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE COMPLAINT WAS NOT CONFIRMED AND NO FOREIGN MATERIAL WAS IDENTIFIED. EVALUATION DID FIND THE BENDING ANGLE IN THE UP DIRECTION DID NOT MEET STANDARD VALUE AND THE PLAY OF THE UP/DOWN KNOB WAS OUT OF STANDARD VALUE DUE TO WEAR OF THE ANGLE WIRE, THE BENDING SECTION COVER ADHESIVE WAS CRACKED, THE UP/DOWN KNOB COULD NOT BE LOCKED SECURELY DUE TO WEAR OF THE FORCEPS ELEVATOR LEVER, THE LIGHT GUIDE LENS WAS DISCOLORED, THE DISPLAYED ULTRASOUND IMAGE WAS DEFECTIVE WITH MISSING ELEMENTS DUE TO DAMAGE ON THE ULTRASONIC CABLE, THE ACOUSTIC LENS WAS DAMAGED, AND MULTIPLE PARTS OF THE SCOPE WERE DAMAGED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS NO INDICATION THAT THE EVENT WAS CAUSED BY A MISUSE OR THAT THE EVENT WAS RELATED TO DESIGN OF THE DEVICE. REPAIR HISTORY WAS REVIEWED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED EVENT. SINCE THE COMPLAINT WAS NOT CONFIRMED AND NO FOREIGN MATERIAL WAS FOUND DURING EVALUATION, A DEFINITIVE ROOT CAUSE OF THE FOREIGN MATERIAL COMING OUT OF THE SCOPE COULD NOT BE IDENTIFIED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE WAS CLEANED USING AN AUTOMATIC ENDOSCOPE REPROCESSOR ON (B)(6) 2022. ON THE MORNING OF (B)(6) 2022, DIRT CAME OUT OF THE TIP OF THE SCOPE AND THERE WAS A STRING OF BLOOD. THE CUSTOMER STOPPED USING THE SCOPE AND DID NOT USE IT ON A PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635955 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown