BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 10147446 · Received June 12, 2020

    Report

    Report Number
    8010047-2020-03310
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    May 18, 2020
    Report Date
    January 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION AND ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE SIX YEARS OR MORE HAVE PASSED SINCE THE DELIVERY OF THE DEVICE, IT IS LIKELY THE PARTS OF THE POWER SUPPLY UNIT DETERIORATED AND THE POWER SUPPLY UNIT FAILED DUE TO REPEATED USE FOR A LONG PERIOD OF TIME.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT DEVICE, BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC. SINCE THE SUBJECT DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF USE THE SUBJECT DEVICE, THE SUBJECT DEVICE COULD NOT BE TURNED THE POWER ON. OLYMPUS SERVICE OPERATION REPAIR CENTER REPLACED THE POWER SUPPLY UNIT OF THE SUBJECT DEVICE TO THE NEW POWER SUPPLY UNIT. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611718 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ OLYMPUS MEDICAL SYSTEMS CORP. CV-180

    Patients

    Seq Age Sex Outcome Treatment
    1