BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11500587 · Received March 17, 2021

    Report

    Report Number
    8010047-2021-03832
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Report Date
    April 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. OMSC SURMISED THAT THIS PHENOMENON ATTRIBUTED TO THE FOLLOWING. -EXCESSIVE STRESS WAS APPLIED TO THE DEVICE BY THE USER HANDLING. -AGING DETERIORATION MAY HAVE CAUSED THE DEFECT BECAUSE OVER 7 YEARS HAVE PASSED SINCE THE DEVICE WAS DELIVERED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. ACCORDING TO THE EVALUATION, OLYMPUS REPAIR CENTER FOUND THE FOLLOWING. THE POWER SUPPLY UNIT HAD A DEFECTIVE. THE TOP COVER OF THE DEVICE HAD A SCRATCH. THE XENON LAMP HAS USED FOR A TOTAL OF 500HOURS. OLYMPUS REPAIR CENTER CLEANED THE DEVICE FROM DUST. 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

    DURING THE PREPARATION FOR USE, THE USER COULD NOT TURN ON THE POWER OF THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401335 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1