BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HD ENDOEYE LAPARO-THORACO VIDEOSCOPE

    MDR report key: 1873431 · Received October 15, 2010

    Report

    Report Number
    8010047-2010-00213
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE DEVICE DID NOT PROVIDE AN IMAGE AND THE UNIT FAILED LEAK TESTING DUE TO CUTS IN THE BENDING SECTION. ADDITIONALLY, THE SWITCHES BUTTONS DID NOT ACTIVATE, AND THE DEVICE FAILED ELECTRICAL SAFETY TESTING DUE TO THE CUTS ON THE BENDING SECTION. THE SOURCE OF THE SWITCH FAILURE WAS ISOLATED TO THE PC BOARD. THE VIDEO CONNECTOR UNIT AND THE SWITCH UNIT WERE REPLACED BUT THERE WAS STILL NO IMAGE. THE EXACT CAUSE OF THE IMAGE PROBLEM COULD NOT BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC PROCEDURE, THE DEVICE "STOPPED WORKING" AND REPORTEDLY EXPERIENCED AN IMAGE LOSS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BUT SIMILAR DEVICE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HD ENDOEYE LAPARO-THORACO VIDEOSCOPE VIDEOSCOPE FET OLYMPUS MEDICAL SYSTEM CORPORATION LTF-VH NA

    Patients

    Seq Age Sex Outcome Treatment
    1