BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 13895600 · Received March 24, 2022

    Report

    Report Number
    8010047-2022-04979
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Report Date
    May 11, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION DATE: 2022/03/07 EVALUATOR: (B)(4)(OMSC_CHU) PHENOMENON: ERROR CODE B30 BEING DISPLAYED DUE TO THE OUTPUT SOCKET INOPERATIVE AND CORRODED. PAE JUDGMENT:PAE APPLICABLE. INVESTIGATION REQUIRED: NECESSARY. TIER CLASSIFICATION: TIER 2. UNIVERSAL FAILURE CODE: CVP8001C. PHENOMENON: ERROR CODE B30 DUE TO FAILURE OF THE PC BOARD. PAE JUDGMENT: PAE APPLICABLE. INVESTIGATION REQUIRED: NECESSARY. TIER CLASSIFICATION: TIER 2. UNIVERSAL FAILURE CODE: CVP8001Y. PHENOMENON: THE CONTACT BETWEEN THE INSTRUMENT AND THE LIGHT SOURCE WORKS POORLY. PAE JUDGMENT: NOT APPLICABLE. INVESTIGATION REQUIRED: NOT NECESSARY. TIER CLASSIFICATION: TIER 3. UNIVERSAL FAILURE CODE: CVP5001Y. CONTAINMENT MEASURES: NO (AT THIS TIME, NO FACTS HAVE BEEN CONFIRMED TO SUGGEST THAT THE REPORTED EVENT MAY EXPAND.)

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO CORRECT INFORMATION PROVIDED ON THE INITIAL REPORT. THE FOLLOWING SECTIONS WERE CORRECTED: G3, THE AWARE DATE SHOULD BE 10-FEB-2022. 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 LEGAL MANUFACTURER'S INVESTIGATION, IT WAS DETERMINED THAT B30 OCCURRED DUE TO CORRODED OUTPUT SOCKET AND FAULTY PC BOARD. THE CAUSE OF CORROSION WAS ATTRIBUTED TO USER¿S HANDLING OF THE DEVICE (INSUFFICIENT WIPING OFF AND DRYING OF THE CONNECTOR). ABRASION APPEARED TO HAVE BEEN THE CAUSE OF THE FAULTY PC BOARD. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    OLYMPUS (OFR) WAS INFORMED THAT THE CUSTOMER EVIS EXERA III XENON LIGHT SOURCE WAS RETURNED FOR SERVICE/REPAIR FOR A REPORTED ¿THE CONTACT BETWEEN THE INSTRUMENT AND THE LIGHT SOURCE WORKS POORLY¿ FOUND DURING PREPARATION FOR USE. UPON INSPECTING AND TESTING, THE SERVICE EVALUATION IDENTIFIED A NO IMAGE MALFUNCTION (REPORTABLE) ALONG WITH THE COMMUNICATION ERROR CODE, B30, BEING DISPLAYED MAINLY WHEN CONNECTING EVIS EXERA III (190) SERIES TYPE ENDOSCOPES. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127815 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown