Olympus Corporation of the Americas: 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.

Recall number

Z-0697-2024

Recalling firm

Olympus Corporation of the Americas

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.

Status

Open, Classified

Initiated

2023-11-06

Posted

2024-01-10

Terminated

not on file

Reason

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

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

WA50040A : 561 units; WA50042A: 857 units

Distribution

Worldwide - US Nationwide distribution.

Lot, serial or model codes

UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers

510(k) numbers

["K190744"]

PMA numbers

not on file

Product code

HET

Firm FEI

2429304

Firm city

Center Valley

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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