BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3D VISUALIZATION UNIT

    MDR report key: 11372175 · Received February 24, 2021

    Report

    Report Number
    8010047-2021-02944
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 31, 2021
    Report Date
    April 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K123365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE REPORT OF OLYMPUS INDIA, OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO BECOMING UNCONTROL SUBJECT DEVICE DUE TO ACCIDENTAL ELECTRONICAL COMPONENTS FAILURE ON THE PRINTED CIRCUIT BOARD OF THE SUBJECT DEVICE, BECAUSE IT HAS BEEN PAST MORE THAN 5 YEARS SINCE THE SUBJECT DEVICE WAS DELIVERED AND IT WAS LONG TERM USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS BEEN NOT RETURNED TO OMSC FOR THE EVALUATION, 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 FROM THE USER THAT NO VIDEO OUTPUTTED FROM THE SUBJECT DEVICE AND THE IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED AT THE REGULAR ROUTINE INSPECTION BY THE BIOMEDICAL ENGINEER OF THE FACILITY. AT THE INCOMING INSPECTION FOR THE REPAIR, OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND DUPLICATED THE REPORTED PHENOMENON. IT WAS FOUND THE PRINTED CIRCUIT BOARD FAILURE WHICH MIGHT HAVE CAUSED THE REPORTED PHENOMENON. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273401 3D VISUALIZATION UNIT 3D VISUALIZATION UNIT FET OLYMPUS MEDICAL SYSTEMS CORP. 3DV-190

    Patients

    Seq Age Sex Outcome Treatment
    1