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Olympus ENDOEYE HD II Rigid Videoscope recallZ-0697-2024 · Olympus Corporation of the Americas · initiated Nov 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Component design/selection

What the company is doing

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

Recall details

Recall number
Z-0697-2024
Status
Open, Classified
Initiated by the company
Nov 6, 2023
Posted by the FDA
Jan 10, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
WA50040A : 561 units; WA50042A: 857 units
Product code
HET
FDA submissions
K190744
Distribution
Worldwide - US Nationwide distribution.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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