Class 2 Device Recall Olympus ENDOEYE HD II Video Telescopes

• Date Initiated by Firm: February 10, 2017
• Date Posted: February 21, 2017
• Recall Status: Terminated on May 09, 2018
• Recall Number: Z-1929-2017
• Recall Event ID: 76488
• 510(K)Number: K111788
• Product Classification: Laparoscope, gynecologic (and accessories) - Product Code HET
• Product: 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
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; PO Box 610; Center Valley PA 18034-0610
• For Additional Information Contact: Laura Storms; 484-896-5688
• Manufacturer Reason for Recall: A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
• FDA Determined Cause: Device Design
• Action: A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.
• Quantity in Commerce: 863 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HET and Original Applicant = OLYMPUS AMERICA, INC.