BEUDAMED
    FDA Recall Terminated

    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

    Recall: Z-1929-2017 · Initiated February 10, 2017

    Recall

    Recall Number
    Z-1929-2017
    Event Number
    76488
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    HET
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 10, 2017
    Posted
    February 21, 2017
    Terminated
    May 9, 2018
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

    Reason

    A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.

    Action

    A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.

    Distribution

    Nationwide

    Quantity

    863 units