BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 12488667 · Received September 17, 2021

    Report

    Report Number
    8010047-2021-11901
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 25, 2021
    Report Date
    November 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DEVICE EVALUATION AND LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE OLYMPUS SERVICE CENTER CONFIRMED THE REPORTED EVENT DUE TO A FAULTY SCOPE SOCKET. THERE WAS ALSO CORROSION AND HEAVY DUST INSIDE THE SCOPE SOCKET. CORROSION WAS ALSO FOUND ON TOP COVER, BOTTOM CHASSIS, FRONT PANEL CHASSIS AND ON LAMP DOOR. THE FRONT PANEL MOUTH WAS CRACKED AND MAIN POWER SWITCH STUCK INTERMITTENTLY. THE OLYMPUS LAMP LIFE METER IS READING OVER 500+ HOUR, LIGHT OUTPUT MEASURE OUT OF RANGE. THE AIR PUMP FLOW RATE MEASURES OUT OF SPECIFICATION. THE FAULTY PARTS WERE REPLACED. THE DEVICE WAS INSPECTED AND PASSED OLYMPUS FUNCTIONAL STANDARDS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ERROR CODE B30 WAS CAUSED BY A RUSTED SCOPE SOCKET WHICH COULD NOT BE ENERGIZED WHEN CONNECTING TO THE SCOPE. THE CAUSE OF RUST IN THE SCOPE SOCKET COULD NOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE USER EXPLAINED THE ERROR DID NOT RESOLVE AFTER ATTEMPTING TO TROUBLESHOOT. THE USER CHANGED THE COMMUNICATION CABLE, USED A DIFFERENT VIDEO SYSTEM CENTER AND CHECKED THE DEVICE FOR DEBRIS. AFTER TROUBLESHOOTING, THE USER ISOLATED THE ISSUE TO THE EXIS EXERA III XENON LIGHT SOURCE AND WANTED TO SEND IN THE DEVICE FOR EVALUATION. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THERE WAS A B30 ERROR ON THE EXIS EXERA III XENON LIGHT SOURCE WHEN CONNECTED TO THE MODEL 190 SCOPE SERIES PRIOR TO AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386334 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CV-190EVIS EXERA III VIDEO SYSTEM| MAJ-1933COMMUNICATION CABLE| MODEL 190 SCOPE SERIESMODEL NUMBER UNKNOWN