BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 11691535 · Received April 20, 2021

    Report

    Report Number
    8010047-2021-05122
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. ACCORDING TO INFORMATION PROVIDED BY OLYMPUS (THAILAND) CO., LTD., THE REPORTED EVENT, ERROR E229, OCCURRED DURING DEVICE PREPARATION PRIOR TO THE START OF THE PROCEDURE. THE INTENDED PROCEDURE WAS ADENOMYOSIS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). HOWEVER, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY A FAILURE OF THE ENDOSCOPE CONNECTED TO THE DEVICE, AS THE DEVICE INSPECTION RESULT BY OLYMPUS (THAILAND) CO., LTD. (OTH) COULD NOT CONFIRM ANY ANOMALIES AND THE SCOPE ID DATA ERROR E229 MEANS SCOPE ID DATA CORRUPTION. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE OLYMPUS ENGINEER VISITED THE USER FACILITY AND CONFIRMED THE REPORTED EVENT. THEN, THIS DEVICE AND THE WA50040A WERE RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS ((B)(6)) CO., LTD. (OTH) FOR INSPECTION. THE DEVICE INSPECTION CONFIRMED FOLLOWINGS; THE REPORTED EVENT WAS NOT REPRODUCED. OTH PERFORMED A LONG RUNNING TEST ON THE DEVICE AND WA50040A BUT NO ERROR MESSAGE OCCURRED. THE DEVICE AND THE WA50040A PASSED INSPECTION. BOTH RETURNED THE DEVICE AND THE WA50040A TO THE USER FACILITY ON MARCH 31, 2021. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AN OLYMPUS ENGINEER AND REPORTED THAT ERROR E229 OCCURRED DURING PREPARATION FOR USE. THIS DEVICE WAS USED IN COMBINATION WITH THE OLYMPUS RIGID VIDEOSCOPE WA50040A. THE CUSTOMER REPLACED THE DEVICE TO ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591309 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER OWN OLYMPUS MEDICAL SYSTEMS CORP. OTV-S200

    Patients

    Seq Age Sex Outcome Treatment
    1