BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 14584182 · Received June 2, 2022

    Report

    Report Number
    8010047-2022-09336
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    April 14, 2022
    Report Date
    July 25, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CALLED THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) SUPPORT TO TROUBLESHOOT THE DEVICE. CUSTOMER REPORTED A NO IMAGE ON THE CV-190. IT WAS CONFIRMED THE CUSTOMER HAD A COMPOSITE VIDEO CABLE CONNECTED FROM COMP OUT PORT ON THE CV-190 TO THE VIDEO IN PORT ON THE OEV-262H MONITOR. TAC INSTRUCTED THE CUSTOMER TO PRESS THE PORT A BUTTON ON THE FRONT PANEL OF THE OEV-262H MONITOR AND SELECT COMPOSITE VIDEO. THE CUSTOMER CONFIRMED THAT THE CV-190 IMAGE APPEARED ON THE OEV-262H MONITOR. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION, DEVICE HISTORY RECORD REVIEW AND ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. THE REVIEW OF THE DHR DID NOT FIND ANY ABNORMALITIES OR ANOMALIES IDENTIFIED DURING PRODUCTION. THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION DETERMINED THE DEFECT WAS RESOLVED BY INPUT SETTING TO COMPOSITE AT THE OEV262H. THE IMPROPER INPUT SETTING MAY TRIGGER THE ISSUE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, NO IMAGE ON THE EVIS EXERA III VIDEO SYSTEM CENTER. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO THE BEGINNING OF A UNKNOWN PROCEDURE. THE SCREEN WAS NOT BEING SHOWN ON THE CAR AND THE WALL MOUNTED MONITOR. THE CABLE WAS DISCONNECTED. THERE WAS NO DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031880 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown