Z-0697-2024Class II

Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center...

Name: Z-0697-2024 Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center...
Creator: Olympus Corporation of the Americas
Published: 2023-11-06
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-11-06 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor... on 2023-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0697-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-06
Posted: 2024-01-10
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.
Product code: HET Laparoscope, Gynecologic (And Accessories)
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.
Root cause tag: design
FDA 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 [email protected] 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.
Product codes and lots: UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0697-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0697-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10

Product code HET

K190744Class IIEndoeye Hd II (Wa50040a, Wa50042a, Wa50050a, Wa50052a)Olympus Winter & Ibe GmbH / cleared 2019-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)