Events

Recall of ENDOEYE Video Telescope

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01141-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01141-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The backup mechanism designed to detect and identify a failed temperature sensor is not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury.
  • Action
    Olympus is advising the customers to inspect stock and quarantine the affected units prior to their return to the sponsor. Upon receiving the affected units, Olympus will perform a short term correction by disabling the "fog-free" function and return the corrected units back to the customers for routine use. A final permanent fix involving a hardware upgrade will restore full functionality of the device is expected to be performed in 2016.

Device

ENDOEYE Video Telescope
  • Model / Serial
    ENDOEYE Video TelescopeENDOEYE 10mm 0 degreesPart #: WA50040AS/N: 622642, 622770, 622774, 622776, 623616, 623617, 623618, 623620, 624087, 624088ENDOEYE 10mm 30 degreesPart #: WA50042AS/N: 622506, 622529, 622530, 622531, 622532, 622533, 622781, 623665, 623667, 623684, 624075, 624094, 624619, 624627ENDOEYE devices repaired with affected spare partPart #: WA50040A or WA500422S/N: 616960, 616963, 617144, 617801, 619863ARTG Number: 121101
  • Product Classification
    Obstetrical and Gynecological Devices
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd