—#204950

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.

FDA product code: HET — Laparoscope, Gynecologic (And Accessories)
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K190744
Affected lot / code info: UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Worldwide - US Nationwide distribution.

Timeline

Recall initiated: 2023-11-06
Posted by FDA: 2024-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.