BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 19125629 · Received April 17, 2024

    Report

    Report Number
    3002808148-2024-03570
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 7, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: E1 (ESTABLISHMENT NAME). ADDITIONAL INFORMATION ADDED TO FIELDS: H3 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    F24149684-1 : [FINAL EVALUATION RESULT] EVALUATION DATE: 2024/04/11 EVALUATOR: (B)(6). PURPOSE OF PROCEDURE: UNKNOWN EVENT:THE IMAGE COLOR WAS ABNORMAL DUE TO FAULTY DP BOARD. PAE JUDGMENT: PAE-NO INVESTIGATION REQUIRED: NO INVESTIGATION REQUIRED TIER CLASSIFICATION: 3 UNIVERSAL FAILURE CODE: CVP1143G CONTAINMENT MEASURES: NO (AT THIS TIME, NO FACTS HAVE BEEN CONFIRMED TO SUGGEST THAT THE REPORTED EVENT MAY EXPAND.) F24149684-2 : [FINAL EVALUATION RESULT] EVALUATION DATE: 2024/04/15 EVALUATOR: (B)(6). PURPOSE OF PROCEDURE: UNKNOWN EVENT:THE IMAGE COLOR WAS ABNORMAL DUE TO FAULTY DP BOARD. PAE JUDGMENT: PAE-NO INVESTIGATION REQUIRED: NO INVESTIGATION REQUIRED TIER CLASSIFICATION: 3 UNIVERSAL FAILURE CODE: CVP1143G EVENT:FRONT PANEL SWITCHES NOT FUNCTIONING PAE JUDGMENT: PAE-YES INVESTIGATION REQUIRED: INVESTIGATION REQUIRED TIER CLASSIFICATION: 2 UNIVERSAL FAILURE CODE: CVP3132 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 THE VIDEO SYSTEM CENTER FRONT PANEL BUTTONS DIDN'T WORK. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024829 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown