BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 19094155 · Received April 11, 2024

    Report

    Report Number
    3002808148-2024-03428
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 26, 2024
    Report Date
    December 18, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON 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. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED THE REPORTED EVENT. THE LOCK MECHANISM AND THE SCOPE DETECTION SLIDE ARE NOT FUNCTIONING, AND FROM THIS, WE PRESUME THAT THE FRONT PANEL BLINKED. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED TO QAD OF SHIRAKAWA PLANT AND WE CANNOT CHECK THE PRODUCT¿S DETAILED STATUS, THUS WE COULD NOT DETERMINE THE ROOT CAUSE. ABOUT ASSEMBLING NON-OLYMPUS PRODUCT, WE FOUND THE DESCRIPTION BELOW IN THE INSTRUCTION MANUAL. WARNING NEVER INSTALL A LAMP THAT HAS NOT BEEN APPROVED BY OLYMPUS. THE USE OF A NONAPPROVED LAMP CAN CAUSE DAMAGE TO THE LIGHT SOURCE AND ANCILLARY EQUIPMENT, MALFUNCTION OR A FIRE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE XENON LIGHT SOURCE HAD CORROSION ON SOCKET PINS AND HAD FRONT PANEL MOUTH DAMAGED. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836970 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown