BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 6746283 · Received July 27, 2017

    Report

    Report Number
    8010047-2017-01102
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 5, 2017
    Report Date
    March 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    PK102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT OEV262H WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). OMSC CHECK THE DEVICE HISTORY RECORD OF THE SUBJECT OEV262H AND NO ABNORMALITY FOUND. OMSC SURMISED THAT THIS PHENOMENON MIGHT HAVE BEEN OCCURRED BY THE FOLLOWING. THE SIGNAL OF THE SUBJECT OEV262H AND/OR UWIT-RX COMBINED WITH THE SUBJECT OEV262H WAS INFLUENCED BY THE HIGH FREQUENCY NOISE FROM ARGON BEAM DIATHERMY THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS FOUND, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE SUBJECT OEV262H WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC). THE USER CHECKED THE SUBJECT OEV262H ON THE FOLLOWING DAY AND REPORTED TO OLYMPUS AS BELOW. - THE SUBJECT OEV262H COULD BE TURNED ON. THE USER FOUND NO ABNORMALITY ON THE LCD SCREEN OF THE SUBJECT OEV262H. THERE WAS POSSIBILITY THAT THE POWER OR OVERHEATING ISSUE AND/OR THE FAULTY OF THE FAN CAUSED THE OVERHEATING OCCURRED. THEREFORE THE SUBJECT OEV262H HAS REQUIRED THE TEST ABOUT CONTINUOUSLY WORKING. THE USER ALSO REPORTED FOLLOWING TO OLYMPUS. - PREVIOUSLY THE USER WITNESSED A FAULT IMAGE WITH THE SUBJECT OEV262H CAUSED BY THE INTERFERENCE FROM THE ARGON BEAM DIATHERMY DURING A PROCEDURE. THE USER TRIED TO REPRODUCE THIS INTERFERENCE USING ANOTHER OEV262H. HOWEVER THIS INTERFERENCE WAS NOT REPRODUCED. OEV262H INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY. IF SIGNIFICANT ADDITIONAL INFORMATION IS FOUND, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE ENDOSCOPIC IMAGE WAS NO LONGER DISPLAYED NORMALLY DURING UNSPECIFIED PROCEDURE. THE USER CONFIRMED THE SUBJECT OEV262H WAS STILL POWERED ON. THE USER REPLACED THE SUBJECT OEV262H WITH AN UNSPECIFIED MONITOR AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529301 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1