BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 10865578 · Received November 18, 2020

    Report

    Report Number
    8010047-2020-09120
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Report Date
    November 19, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4) LIMITED LIABILITY COMPANY (OMC) FOR REPAIR. IN THE EVALUATION OF OMC THE FOLLOWING WAS CONFIRMED; THE POWER SUPPLY CONVERTER OF THE DEVICE WAS DEFECTIVE. NO ABNORMALITIES WERE NOTED IN THE APPEARANCE OF THE DEVICE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS MANUFACTURED OVER 7 YEARS AGO. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY THAT THE REPORTED EVENT WAS CAUSED BY THE FAILURE OF THE CONVERTER IN THE POWER SUPPLY UNIT DUE TO AGING DETERIORATION DUE TO LONG-TERM USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE DEVICE DID NOT START UP. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330197 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1