BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 13042751 · Received December 20, 2021

    Report

    Report Number
    8010047-2021-16409
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 23, 2021
    Report Date
    February 21, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS INDIA (OMSI). OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON (POWER OFF ISSUE) COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON THE INFORMATION FROM OLYMPUS OMSI. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED POWER OFF ISSUE WAS NOT DUPLICATED, AND ALSO FOUND THAT THE SUBJECT DEVICE FUNCTIONED WITHOUT ANY PROBLEMS. 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT OLYMPUS MEDICAL SYSTEMS (B)(4) WAS RECEIVED INFORMATION FROM THE USER REGARDING A POWER FAILURE OF THE SUBJECT DEVICE DURING LAPAROSCOPIC SURGERY AND THAT THE FIELD SERVICE ENGINEER OF (B)(4) CONFIRMED THROUGH A VIDEO CALL THAT THE POWER OF THE SUBJECT DEVICE WAS TURNED OFF FIFTEEN TO TWENTY MINUTES AFTER STARTUP. WHEN THE POWER OF THE SUBJECT DEVICE WAS CYCLED, THE SAME POWER OFF ISSUE OCCURRED FIVE TO TEN MINUTES LATER, AND THE TOP SIDE OF THE REAR PANEL HAD BEEN HEATED AT THAT TIME. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940616 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown