BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 10944729 · Received December 4, 2020

    Report

    Report Number
    8010047-2020-09810
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Report Date
    February 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170355479
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE IS LIKELY EXTERNAL FORCE WAS APPLIED CREATING CHIPPING OF THE ADHESIVE AT THE DISTAL END. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "·IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE DO NOT APPLY SHOCK TO THE DISTAL END OF THE INSERTION SECTION, PARTICULARLY THE ULTRASOUND TRANSDUCER AND THE OBJECTIVE LENS SURFACE AT THE DISTAL END. VISUAL ABNORMALITIES MAY RESULT.".

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR PHYSICAL EVALUATION. THE INVESTIGATION IS ONGOING. PHYSICAL EVALUATION OF THE RETURNED DEVICE REVEALS THE FOLLOWING: THE UM CONNECTOR IS NOT ATTACHED, THEREFORE LEAK TEST CAN NOT BE PERFORMED. UM IMAGE WAS NOT DETECTABLE DUE TO MULTIPLE BROKEN ELEMENTS. THE FORCEPS COVER GLUE WAS PEELING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED WHILE PREPARING A IS EXERA II ULTRASOUND GASTROVIDEOSCOPE FOR USE, SOMEONE TRIPPED OVER THE DEVICE AND THE U-CONNECTOR WAS COMPLETELY BROKEN OFF WITH WIRES HANGING OUT. THERE WAS NO PATIENT CONTACT/IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409132 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170355479

    Patients

    Seq Age Sex Outcome Treatment
    1