BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 12551716 · Received September 30, 2021

    Report

    Report Number
    8010047-2021-12497
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 6, 2021
    Report Date
    November 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS EVALUATED AT OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI). AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. -THE TOUCH PANEL BECAME BLANK DUE TO A FAILURE OF THE CP BOARD. -TOUCH PANEL ERROR E333 WAS DETECTED IN THE ERROR LOG OF THE DEVICE, BUT ERROR E333 DID NOT RECUR DURING EVALUATION. COMMUNICATION BETWEEN THE TOUCH PANEL AND THE CP BOARD MAY NOT HAVE BEEN PERFORMED DUE TO A FAILURE OF THE CP BOARD. -SCOPE ID DATA ERROR E228 DID NOT RECUR. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE TOUCH PANEL MAY HAVE REPEATEDLY RESTARTED DUE TO A FAILURE OF THE CP BOARD. THE CAUSE OF THE CP BOARD FAILURE COULD NOT BE DETERMINED. IN ADDITION, TOUCH PANEL ERROR E333 MAY HAVE OCCURRED DUE TO A TOUCH PANEL FAILURE. THE CAUSE OF THE TOUCH PANEL FAILURE COULD NOT BE IDENTIFIED. THE CAUSE OF THE SCOPE ID DATA ERROR E228 COULD NOT BE DETERMINED FROM THE FOLLOWING INFORMATION. -ERROR E228 OCCURRED ONLY ONCE. -THERE WAS NO ABNORMALITY IN THE DEVICE HISTORY RECORD. 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 · 0

    THE DEVICE IS PLANNED TO BE RETURNED TO OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI) BUT HAS NOT BEEN RETURNED YET. 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 · 0

    AN OLYMPUS FIELD SERVICE ENGINEER CONFIRMED THAT DURING THE LAPAROSCOPIC RADICAL PROSTATECTOMY, THE DEVICE WORKED NORMALLY FOR APPROXIMATELY TWO HOURS AND THEN SUDDENLY RESTARTED. THE TOUCH PANEL OF THE DEVICE RESTARTED INTERMITTENTLY AND TOUCH PANEL ERROR E333 WAS DISPLAYED. DURING THE REBOOT, THE MONITOR IMAGE WAS NOT DISPLAYED AND ONLY THE SCOPE SWITCH INFORMATION WAS DISPLAYED. IN ADDITION, THE TOUCH PANEL OF THE DEVICE RESTARTED WHEN THE OLYMPUS ENDOEYE 3D DEVICE WAS DISCONNECTED FROM THE DEVICE AND ALL CONNECTIONS WERE DISCONNECTED. AFTER REMOVING THE POWER CORD, THE POWER INDICATOR LIT UP FAINTLY. IN ADDITION, SCOPE ID DATA ERROR OCCURRED ONLY ONCE. THE ERROR CODE E333 MEANS THAT THE VIDEO SYSTEM CENTER HAS BROKEN DOWN, AND THE ERROR CODE E228 MEANS THAT THE ENDOSCOPE HAS BROKEN DOWN. THE USER COMPLETED THE PROCEDURE WITH THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454688 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown