BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 10500418 · Received September 8, 2020

    Report

    Report Number
    8010047-2020-06265
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Report Date
    December 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS EUROPA SE & CO. KG (OEKG). OEKG FOUND THE FOLLOWING MALFUNCTIONS ON THE SUBJECT DEVICE. FAILURE OF POWER SUPPLY SWITCH. TOP COVER SCRATCHES, FRONT PANEL CRACKS. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE PAST SIMILAR CASES, THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING CAUSES. FAILURE OF POWER SUPPLY SWITCH MIGHT BE CAUSED BY THE LONG-TERM USE(DELIVERY IN SEPTEMBER 2013.) TOP COVER SCRATCHES AND FRONT PANEL CRACKS MIGHT BE CAUSED BY COLLISION/CONTACT DUE TO SOME HARD FOREIGN OBJECT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS SERVICE OPERATION REPAIR CENTER WAS INFORMED FROM THE FACILITY THAT IN UNSPECIFIED TIMING THE SUBJECT DEVICE COULD NOT BE TURNED THE POWER ON. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER, IT WAS FOUND THE POWER SWITCH UNIT AND THE POWER SUPPLY UNIT OF THE DEVICE WAS BROKEN. 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
    967377 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1