BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE XENON LIGHT SOURCE

    MDR report key: 9920037 · Received April 3, 2020

    Report

    Report Number
    8010047-2020-01974
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 9, 2020
    Report Date
    May 12, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO KEYMED LTD, (OKM). OKM EVALUATED THE SUBJECT DEVICE AND CONFIRMED AS FOLLOWS; THE PREVIOUSLY SERVICE BY OLYMPUS WAS CONDUCTED FOR THE SUBJECT DEVICE IN SEPTEMBER 13TH, 2019. THE REPORTED ENDOSCOPIC IMAGE LOSS WAS NOT DUPLICATED DURING EVEN SOAK TEST. THE EXTERNAL AND INTERNAL OF THE SUBJECT DEVICE WERE IN GOOD CONDITION, BUT THERE WERE SOME DUSTS. THE OUTPUT CONNECTOR WAS CRACKED. A NON-OLYMPUS LAMP WAS FITTED AT 200H USAGE. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT 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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AN ENDOSCOPY WAS INTERRUPTED BECAUSE THE ENDOSCOPIC IMAGE DISAPPEARED. THE USER FACILITY CHANGE THE ENDOSCOPE TO ANOTHER ONE AND THE ENDOSCOPIC IMAGE DISPLAYED FOR A MOMENT, BUT THEN WENT OFF AGAIN. AT THAT TIME, THE PATIENT WAS ALREADY UNDER ANESTHESIA. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. IT WAS REPORTED THAT USER FACILITY WOULD PERFORM ANOTHER PROCEDURE LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386245 EVIS LUCERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORP. CLV-290SL

    Patients

    Seq Age Sex Outcome Treatment
    1