BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11153115 · Received January 12, 2021

    Report

    Report Number
    8010047-2021-01224
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    October 13, 2020
    Report Date
    January 29, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. THE ISSUE WAS FOUND TO BE A DEFECT OF THE VIDEO CONNECTOR SOCKET. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE IS LIKELY THE AMOUNT OF USE AND AGE OF THE DEVICE (OVER 6 YEARS), CREATING WEAR IN THE PIN OF THE SCOPE SOCKET AND FAILURE DUE TO REPEATED USE. THIS CREATES A CONTACT FAILURE OF THE CONNECTOR, INTERFERING WITH IMAGE TRANSMISSION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE ENDOSCOPIC IMAGE DID NOT APPEAR WHEN AN OLYMPUS 190 SERIES ENDOSCOPE WAS CONNECTED TO THE DEVICE. THEN, OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED AND FOUND THE DEFECT OF THE VIDEO CONNECTOR SOCKET. IT WAS ALSO FOUND THE HEAVY DUST INSIDE THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51056 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1