BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENON LAMP

    MDR report key: 11044070 · Received December 21, 2020

    Report

    Report Number
    8010047-2020-10726
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    June 26, 2020
    Report Date
    December 21, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCT
    UDI-DI
    04953170355950
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FOR NON-FATAL SERIOUS INJURY/DEVICE MALFUNCTION HAS BEEN STORED UNDER THE COVID-19 PANDEMIC IN ACCORDANCE WITH THE GUIDANCE PUBLISHED BY FDA, POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC. THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMCS CHECKED THE OUTSIDE OF THE DEVICE, THERE WAS NO ABNORMALITY. WHEN OMSC ATTACHED THE DEVICE TO THE OMSC DEVICE (CLV-S190) AND CONFIRMED THE WORK OF OMSC DEVICE (CLV-S190), THERE WAS NO ABNORMALITY. THE EXACT CAUSE WAS UNKNOWN; HOWEVER, OMSC ASSUMED A POTENTIAL CAUSE AS FOLLOWS. THE XENON LIGHT SOURCE USING THE DEVICE DID NOT WORK PROPERLY TEMPORARILY BY SOME CAUSE.

    Description of Event or Problem · 1

    DURING A PROCEDURE WITH THE CLV-S190 AND THE DEVICE, A CLV LAMP ERR E102 APPEARED ON THE MONITOR. THE USER COMPLETED THE PROCEDURE. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515522 XENON LAMP XENON LAMP GCT OLYMPUS MEDICAL SYSTEMS CORP. MD-631 17LBC1102 04953170355950

    Patients

    Seq Age Sex Outcome Treatment
    1