BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 12416346 · Received September 2, 2021

    Report

    Report Number
    8010047-2021-11160
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 11, 2021
    Report Date
    December 13, 2021
    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
    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 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. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE B30 ERROR LIKELY OCCURRED DUE TO THE SCOPE THAT WAS CONNECTED AT THE TIME OF THE PHENOMENON. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) SUPPORT SPOKE TO THE CUSTOMER TO TROUBLESHOOT THE DEVICE. THE CUSTOMER CONFIRMED THAT DURING CASE SET UP, B30 COMMUNICATION ERROR OCCURRED WITH MULTIPLE 190 SERIES SCOPES. THE CUSTOMER CONFIRMED THAT THE ERROR WAS CLEARED BEFORE TESTING MULTIPLE SCOPES. THE COMMUNICATION CABLE WAS RESEATED HOWEVER, THE B30 ERROR AND NO IMAGE ISSUE PERSISTED INTERMITTENTLY. THE CUSTOMER STATED THAT THE SCOPE SOCKET WAS FREE OF DUST. TAC OFFERED TO SEND THE QRG ON B30 TROUBLE SHOOTING AND CLEANING KIT MAJ-2087 BUT THE CUSTOMER DECLINED AND OPTED TO SEND IN THE CLV-190 TO OLYMPUS FOR REPAIR EVALUATION. THE CUSTOMER LATER REACHED BACK OUT AND REQUESTED TO CANCEL THE RETURN MERCHANDISE AUTHORIZATION. THE CUSTOMER CONFIRMED THAT THE ISSUE WAS RELATED TO ONE OF THE SCOPES AND NOT THE CLV-190. THE DEVICE WILL NOT BE SENT IN FOR REPAIR EVALUATION. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE EVIS EXERA III XENON LIGHT SOURCE DISPLAY A B30 COMMUNICATION ERROR. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313983 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 MAJ-2087