BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 11234879 · Received January 27, 2021

    Report

    Report Number
    8010047-2021-01906
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 5, 2021
    Report Date
    June 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO OLYMPUS REPAIR CENTER, BUT NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THEREFORE, OMSC COULD NOT CONFIRM THE DEVICE. ACCORDING TO THE EVALUATION, THE FOLLOWING WAS FOUND. OLYMPUS REPAIR CENTER COULD CONFIRM THE REPORTED PHENOMENON. THERE WERE DEPOSITS ON THE INNER CIRCUIT BOARD. THE TOP COVER AND CHASSIS WERE SCRATCHED. THE FRONT PANEL HAD A FAILURE. THE REAR PANEL HAD RUST. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. OMSC SURMISED THAT THIS PHENOMENON ATTRIBUTED TO THE FAILURE INNER CIRCUIT BOARD BY AN ACCIDENTAL FAILURE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE PREPARATION FOR USE, THE USER TURNED ON THE DEVICE, HOWEVER, THE LEDS OF THE FRONT PANEL DID NOT FLASH. ALSO, THE COLOR BAR WAS DISPLAYED ON THE ENDOSCOPIC IMAGE OF THE MONITOR. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135343 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER OWN OLYMPUS MEDICAL SYSTEMS CORP. OTV-S200

    Patients

    Seq Age Sex Outcome Treatment
    1