BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 1942745 · Received December 17, 2010

    Report

    Report Number
    8010047-2010-00249
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY REPORTEDLY REPLACED THE FUSE AFTER THE EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT DUPLICATE THE COMPLETE LOSS OF POWER, HOWEVER, THE OUTPUT SOCKET AND THE AIR JOINT WERE BOTH WORN, AND THE LAMP LIFE METER WAS READING ZERO HOURS, INDICATING THAT THE XENON BULB NEEDED TO BE REPLACED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. BASED UPON THE INFO PROVIDED BY THE USER, IT APPEARS THE FUSE OPENED FOR UNK REASONS, LEADING TO THE LOSS OF POWER. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TYPE OF ENDOSCOPIC PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF POWER, AND THE IMAGE WAS LOST. THE PROCEDURE WAS DELAYED BY APPROX FIFTEEN MINS, AND COMPLETED WITH THE USE OF ANOTHER LIGHT SOURCE. THERE WAS NO REPORT OF ANY PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIS EXERA II XENON LIGHT SOURCE LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1