BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11863103 · Received May 21, 2021

    Report

    Report Number
    8010047-2021-06604
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    July 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    UDI-DI
    04953170298622
    PMA / PMN Number
    EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LM INVESTIGATION. THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. THE LM REPORTS THAT THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE LEGAL MANUFACTURER PROVIDED THE FOLLOWING POSSIBLE CAUSE FOR THE REPORTED EVENT ARE PRESUMED AS FOLLOWS: THE FOLLOWING WAS SURMISED BASED ON THE INVESTIGATION RESULTS. ·THE INDICATED PHENOMENON WAS CAUSED TEMPORALLY BY MALFUNCTION OF THE DIGITAL LIGHT SOURCE CABLE OR POOR COMMUNICATION. AS A RESULT OF THE DHR REVIEW, IT WAS CONFIRMED THAT THERE WAS NO ABNORMALITY IN MANUFACTURING, CONCESSION, AND VARIATION.

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, THE TECHNICAL ASSISTANCE CENTER (TAC) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING THE UNIT. THE CUSTOMER REPORTED THE LAMP WAS REPLACED LAST MONTH AND THE LAMP IS AT 200 HOURS WITH THE AUTO AND BRIGHTNESS SETTING IN THE MIDDLE AT 0. TAC INSTRUCTED THE CUSTOMER TO ENSURE THE LIGHT SOURCE CABLE WAS SECURE ON THE CV-190 AND CLV-190. THE CUSTOMER PUSHED IN ON THE CABLE AND HEARD A CLICK. TAC INSTRUCTED THE CUSTOMER TO OBTAIN A SCOPE AND TEST BY CUPPING HAND AND MOVING SCOPE IN AND OUT, CUSTOMER STATED IT IS MUCH BETTER. THE CUSTOMER REPORTED THAT THEY HAVE CASES TOMORROW, AND WILL TEST IN THE PROCEDURES. TAC REPORTED THAT THREE UNSUCCESSFUL ATTEMPTS WERE MADE TO FOLLOW UP WITH CUSTOMER AND THE ISSUE WAS CONSIDERED RESOLVED. IN ADDITION, THE UNIT WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. A REVIEW OF THE INSTRUMENT HISTORY DID NOT SHOW A SERVICE/REPAIR FOR THIS UNIT SINCE THE DATE OF PURCHASE ON (B)(6) 2019. 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 USER FACILITY REPORTED THAT FOR THE PAST MONTH THE CLV-190 IS NOT AUTO ADJUSTING THE LIGHT. THE LIGHT IS TOO BRIGHT DURING LOWER AND UPPER ENDOSCOPY PROCEDURES. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758876 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1