Events

Recall of Device Recall Olympus ENDOEYE HD II Video Telescopes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus Corporation of the Americas.

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
    76488
  • Event Risk Class
    Class 2
  • Event Number
    Z-1929-2017
  • Event Initiated Date
    2017-02-10
  • Event Date Posted
    2017-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153345
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laparoscope, gynecologic (and accessories) - Product Code HET
  • 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.

Device

Device Recall Olympus ENDOEYE HD II Video Telescopes
  • Model / Serial
    All serial numbers
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product 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
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • Manufacturer Address
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA