BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA VIDEO SYSTEM CENTER

    MDR report key: 17770075 · Received September 18, 2023

    Report

    Report Number
    3002808148-2023-09993
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 27, 2023
    Report Date
    November 14, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170141546
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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, THE ROOT CAUSE FOR THE DEFECTIVE SCOPE CONNECTOR COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    D2 : ADDITIONAL PROCODES FDF, FDS. E2 : (B)(6). THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND: THE SCOPE CONNECTOR WAS DEFECTIVE, CAUSING NOISY IMAGE OCCASIONALLY. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A POOR CONTACT ISSUE WHILE USING THE VISERA VIDEO SYSTEM CENTER. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (LAPAROSCOPIC CHOLECYSTECTOMY ) AND WAS COMPLETED USING THE SAME DEVICE. THE PATIENT WAS NOT UNDER ANESTHESIA AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146236 VISERA VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER NWB SHIRAKAWA OLYMPUS CO., LTD. OTV-S7V 04953170141546

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLV-S45