BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 12073658 · Received June 28, 2021

    Report

    Report Number
    8010047-2021-08049
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Report Date
    July 29, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CHECKED THE PHOTOS PROVIDED BY OLYMPUS KOREA CO., LTD. (OKR) AND FOUND THAT THE ULTRASOUND TRANSDUCER COVER WAS COMPLETELY PEELED OFF, SO IT IS POSSIBLE THAT EXCESSIVE EXTERNAL FORCE WAS APPLIED TO THIS DAMAGED PART. AS A RESULT, IT IS POSSIBLE THAT THE ULTRASOUND TRANSDUCER WAS ALSO DAMAGED DUE TO THE APPLICATION OF AN EXTERNAL FORCE. THE INSTRUCTION MANUAL PROVIDES PRECAUTIONS FOR HANDLING THE DEVICE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS KOREA CO., LTD. (OKR) FOR EVALUATION. OKR INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THE AMOUNT OF WATER SUPPLIED WAS OUT OF THE STANDARD DUE TO THE CLOGGING OF THE AIR/WATER NOZZLE. THERE WAS A GAP IN THE ADHESIVE OF THE BENDING SECTION RUBBER. THERE WAS A LEAKAGE FROM THE ULTRASONIC ACOUSTIC LENS DUE TO DAMAGE. THE ULTRASONIC IMAGE WAS DAMAGED DUE TO A FAILURE OF THE ULTRASONIC ACOUSTIC LENS. THE ULTRASONIC VIBRATOR BROKE DOWN DUE TO THE BROKEN ULTRASONIC CABLE. THE ULTRASONIC ACOUSTIC LENS FAILED, AND THE PROBE UNIT WAS PARTIALLY MISSING. 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 BY THE USER THAT DURING THE PREPARATION FOR USE, IT WAS FOUND THAT THE ULTRASONIC ACOUSTIC LENS OF THE PROBE UNIT WAS BROKEN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970144 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT260

    Patients

    Seq Age Sex Outcome Treatment
    1