BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 2890619 · Received November 21, 2012

    Report

    Report Number
    2890619
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THERE ARE TWO NEW CLV190 SYSTEMS IN THE ENDOSCOPY DEPARTMENT; EACH SYSTEM IS APPROXIMATELY 2 MONTHS OLD. SYSTEM #1 - COULD NOT WHITE BALANCE THE SYSTEM - ERROR CODE E311 WAS GENERATED. THIS PROBLEM OCCURRED ON THREE DIFFERENT OCCASIONS. EACH TIME A PATIENT WAS SEDATED AND ON THE TABLE WHEN THE FAILURE OCCURRED & THE PATIENT HAD TO BE MOVED. OLYMPUS WAS CALLED EACH TIME & THE LIGHT SOURCE SENT IN FOR REPAIR. LIGHT SOURCE IS STILL OUT FOR REPAIR WITH NO FEEDBACK FROM OLYMPUS REGARDING WHAT THE PROBLEM IS. SYSTEM #2 - LIGHT SOURCE ON THE 2ND SYSTEM DOES NOT RECOGNIZE THE NEW 190 SCOPES FOR WHICH THE LIGHT SOURCE WAS DESIGNED. THE LIGHT SOURCE WAS SENT IN FOR REPAIR. A LOANER 190 LIGHT SOURCE WAS RECEIVED BUT IT TOO FAILED - ONLY THE SECONDARY LAMP WOULD WORK, NOT THE PRIMARY. OLYMPUS THEN SENT IN A 2ND LOANER 190 LIGHT SOURCE. THE HOSPITAL'S ORIGINAL EQUIPMENT HAS BEEN OUT FOR 2.5 WEEKS WITH NO INFORMATION PROVIDED BY OLYMPUS REGARDING THE PROBLEM WITH THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LIGHT SOURCE KOG OLYMPUS AMERICA, INC. CLV 190 *
    2 OLYMPUS LIGHT SOURCE KOG OLYMPUS AMERICA, INC. CLV 190 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *