BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 17940476 · Received October 16, 2023

    Report

    Report Number
    3002808148-2023-11324
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 18, 2023
    Report Date
    December 6, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170386077
    PMA / PMN Number
    K202646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO G2 (INADVERTENTLY SELECTED HEALTHCARE PROFESSIONAL STATUS). 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 ALTHOUGH THERE IS A POSSIBILITY THAT TEMPORALLY ELECTRICAL CONTACT FAILURE, CAUSE COULD NOT BE DETERMINED BECAUSE THE DEVICE IN QUESTION WAS NOT RETURNED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    AFTER THE SURGERY, THE CLINICAL SPECIALIST UNPLUGGED THE PADDLE, CLEANED THE GOLD CONTACTS AND THE ISSUE DID NOT OCCUR AGAIN. THE CUSTOMER SPOKE WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE VIDE SYSTEM INSTRUCTION MANUAL WAS REFERENCED AND THE CUSTOMER WAS ADVISED THAT BOTH ERRORS ARE SCOPE COMMUNICATION ERRORS. THE TAC RECOMMENDED THAT THE CONTACT OF THE SCOPES BE WIPED WITH ISOPROPYL ALCOHOL AND THEN TRY CONNECTING THE VIDEOSCOPES AGAIN. THE CUSTOMER BELIEVED THE ISSUE TO BE THE VIDEO SYSTEM. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA ELITE II VIDEO SYSTEM CENTER HAD AN ERROR E227 GIVEN AND NO IMAGE WAS DISPLAYED ON THE SCREEN AND E216 ERROR MESSAGE AND THERE WAS NO IMAGE WHEN THE ENDOEYE HD II RIGID VIDEOSCOPE WAS CONNECTED WHICH OCCURRED IN THE MIDDLE OF A SURGERY. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: TO CAPTURE THE OTHER REPORTED OTV-S300 DEVICE-OTV-S300 7040708 - (B)(6). TO CAPTURE THE OTHER REPORTED WA50042A DEVICES: (B)(6). SERIAL NUMBER: (B)(6). SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683601 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S300 04953170386077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown