BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 19650071 · Received July 1, 2024

    Report

    Report Number
    3002808148-2024-05975
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 19, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170356384
    PMA / PMN Number
    K111756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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. IT HAS BEEN OVER 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE PHENOMENON ¿FRONT PANEL SWITCHES STOPPED OPERATION¿ OCCURRED DUE TO FAILURE OF THE RECEPTACLE UNIT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    F24276771-1 : [EVALUATION FOR MDR SUBMISSION BY COE]. EVALUATION DATE: 2024/6/27. EVALUATOR: (B)(6). PURPOSE: PERIODIC INSPECTION. (INTAKE AND INSPECTION INFORMATION): EVENT: PROCESSOR FRONT PANEL BUTTON AUTOMATICALLY TURN OFF.: DUE TO FAULTY RECEPTACLE UNIT. PAE JUDGMENT: PAE YES. INVESTIGATION REQUIRED: NECESSARY. TIER CLASSIFICATION: 2. UNIVERSAL FAILURE CODE: CVP3132Y. OTHER EVENTS ARE TIER 3 (PAE NO) AND DO NOT REQUIRE INVESTIGATION. (INSPECTION INFORMATION): EVENT: CVP1142F-FLICKERING IN IMAGE DUE TO FAULTY RECEPTACLE UNIT. EVENT: CVP3112A-FRONT PANEL SWITCHES ARE DEFORMED. CONTAINMENT MEASURES: NO (AT THIS TIME, NO FACTS HAVE BEEN CONFIRMED TO SUGGEST THAT THE REPORTED EVENT MAY EXPAND.).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER PROCESSOR FRONT PANEL BUTTON GETS TURNED OFF AUTOMATICALLY. THE EVENT OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544397 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FDF SHIRAKAWA OLYMPUS CO., LTD. CV-V1 04953170356384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown