Class 2 Device Recall Olympus ENDOEYE HD II

• Date Initiated by Firm: November 06, 2023
• Date Posted: January 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0697-2024
• Recall Event ID: 93601
• 510(K)Number: K190744
• Product Classification: Laparoscope, gynecologic (and accessories) - Product Code HET
• Product: Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
• Code Information: UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers
• FEI Number: 2429304
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
• FDA Determined Cause: Component design/selection
• Action: UPDATE: On 2/9/24 Olympus issued Correction to original letter dated November 6, 2023, regarding the IFU references in #2. The purpose of this Field Corrective Action is to reinforce the requirement in the IFU that users inspect the image prior to a clinical procedure (as described in Section 4.3.3 and 4.4), always have a spare laparoscope available (as described in Section 2.5 General Safety Notes) and to check the image for the spare equipment. Olympus issued Urgent Medical Device Correction letter on November 6, 2023 to US Operating Room Manager, Risk Management Department. Letter states reason for recall, health risk and action to take: This Field Corrective Action reminds customers to follow the steps in the instructions for use, especially to inspect the image prior to a clinical procedure, and always have a spare laparoscope available. Olympus is currently investigating technical solutions to address this issue. Carefully read the content of this notification. 2. Please make sure that all medical personnel are completely knowledgeable and thoroughly trained in the ENDOEYE HD II Instructions For Use (IFU). The purpose of this Field Corrective Action is to reinforce the requirement in the IFU that users inspect the image prior to a clinical procedure (as described in Section 7.4 Testing), always have a spare laparoscope available (as described in Section 2.5 General Dangers, Warnings and Cautions) and to check the image for the spare equipment. 3. If you have further distributed this product, identify your customers and forward them this Customer Notification. Please appropriately document your notification process and let us know the end-customer feedback accordingly. 4. Complete the enclosed response form and return it to our third-party partner, Sedgwick, via e-mail at olympus5225@sedgwick.com or by fax 866-551-2707. For any questions about the acknowledgement form, please call the Sedgwick team at 866-875-0524. If you require additional information o
• Quantity in Commerce: WA50040A : 561 units; WA50042A: 857 units
• Distribution: Worldwide - US Nationwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HET