BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1170008 · Received September 12, 2008

    Report

    Report Number
    8010047-2008-00157
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF A COMPLETE LOSS OF IMAGE, BUT WAS OBSERVED ONLY ON AN INTERMITTENT BASIS. THE SOURCE OF THE DIFFICULTY WAS ISOLATED TO A DAMAGED CHARGE COUPLED FLEXIBLE PRINTED CIRCUIT BOARD. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THE IMAGE TURNED COMPLETELY GREEN, AND NO IMAGE WAS VISIBLE. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A SIMILAR, BUT DIFFERENT DEVICE AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II PEDIATRIC COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK