BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 15562066 · Received October 7, 2022

    Report

    Report Number
    3002808148-2022-02886
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 16, 2022
    Report Date
    December 7, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. IT HAS BEEN OVER 10 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, IT WAS CONFIRMED THAT THE EMERGENCY LIGHTS CONTINUED TO TURN ON DUE TO THE USE OF NON-OLYMPUS LAMPS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALLED INTO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) PERSONNEL TO REPORT HIS ISSUE. DURING THE CALL, THE CUSTOMER CONFIRMED THE SPARE LAMP WAS ON. HE WENT ON TO NOTE THAT THE BULB WAS NOT REPLACED SINCE MARCH OF THE PREVIOUS YEAR AND IS ¿SHOWING 0¿. DURING THE CALL, THE CUSTOMER SWAPPED OUT THE BULB WITH A DIFFERENT ONE FROM ANOTHER UNIT AND IT WAS STILL ¿SHOWING 0¿. TAC ASKED THE CUSTOMER AND FOUND OUT THAT A 3RD PARTY BULB WAS BEING USED AND THE AT THE CUSTOMER WAS FIRMING CLOSING THE DOOR. THEN TAC RECOMMENDED CHANGING THE BULB AND USING AN MAJ-1817 AS WELL AS THE REST INDICATOR. THE CUSTOMER INSTEAD OPTED TO SEND THE UNIT IN FOR REPAIR. THE DEVICE WAS RETURNED, AND AN INITIAL EVALUATION WAS CONDUCTED BY OLYMPUS; HOWEVER, INVESTIGATION IS ONGOING. DURING THE INITIAL EVALUATION, THE USER¿S REPORT WAS CONFIRMED. THE SUBJECT DEVICE WAS BURNED IN FOR SEVERAL HOURS AND THE 3RD PARTY LAMP WAS CAUSING THE USER¿S REPORTED FAILURE TO OCCUR. OLYMPUS STRONGLY RECOMMENDS THE CUSTOMER REPLACING THE LAMP WITH AN OLYMPUS-APPROVED MODEL FOR OPTIMAL PERFORMANCE. ADDITIONALLY, THE SOCKET SLIDER SWITCH WAS FOUND WORN AND CAUSING INTERMITTENT USE OF HIGH INTENSITY MODE. CORROSION WAS DISCOVERED INSIDE THE AIR PUMP TUBING, AND THE FLOW RATE WAS OUT OF SPECIFICATION. THERE WAS A SCRATCH NOTED ON THE TOP COVER. NO OTHER PHYSICAL ABNORMALITIES WERE NOTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HIS OLYMPUS EVIS EXERA III XENON LIGHT SOURCE¿S MAIN LAMP WOULD NOT IGNITE, CAUSING THE SPARE LAMP TO COME ON DURING A PROCEDURE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076970 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown