BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 11593464 · Received March 30, 2021

    Report

    Report Number
    8010047-2021-04377
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 5, 2021
    Report Date
    May 28, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OAZ, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE ACCIDENTAL FAILURE OF THE ELECTRICAL COMPONENT FOR VIDEO TRANSMISSION ON THE ELECTRICAL CIRCUIT BOARD, BECAUSE MORE THAN THREE YEARS HAD PASSED SINCE THE MANUFACTURING OF THE SUBJECT DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED EVENT WAS DUPLICATED, AND ALSO THAT THE VIDEO CONNECTOR SOCKET WAS LOOSE AND CORRODED. THEN, (B)(4) EXCHANGED THE VIDEO CONNECTOR SOCKET TO NEW ONE. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER FACILITY THAT DURING THE ROUTINE MAINTENANCE OF THE SUBJECT DEVICE BY THE BIOMEDICAL ENGINEER OF THE FACILITY, IT WAS FOUND THAT THE IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED WHILE CERTAIN ENDOSCOPES ESPECIALLY DUODENOSCOPES WAS CONNECTED TO THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490209 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1