BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 13942655 · Received March 29, 2022

    Report

    Report Number
    8010047-2022-05244
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 6, 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
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALLED THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) TECHNICAL SUPPORT TO TROUBLESHOOT THE DEVICE FOR IMAGE WOULD FREEZE ON THE MONITOR. TAC INSTRUCTED THE CUSTOMER TO TRY DIFFERENT SCOPES AND THE IMAGE WOULD BE GREEN. TAC ALSO INSTRUCTED THE REPORTER TO REPLACE THE BULB ON THE LIGHT SOURCE SINCE 500 HOURS WAS REPORTED BY THE REPORTER ON THE LIGHT SOURCE, USED IN COMBINATION WITH THE EVIS EXERA III VIDEO SYSTEM CENTER. 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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 6 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, AND THE INABILITY TO EVALUATE THE DEVICE AND REPRODUCE THE EVENT, THE ROOT CAUSE OF THE FROZEN IMAGE COULD NOT BE IDENTIFIED. HOWEVER, IT IS LIKELY THE CAUSE IS RELATED TO AN ABNORMALITY ON THE SCOPE SIDE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS, THE IMAGE WOULD FREEZE AND GOES GREEN WITH DIFFERENT SCOPES ON THE EVIS EXERA III VIDEO SYSTEM CENTER. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782455 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 OLYMPUS LIGHT SOURCE (MODEL UNKNOWN)