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ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE recallZ-0645-2024 · Olympus Corporation of the Americas · initiated Nov 20, 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

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

FDA root cause category: Labeling Change Control

What the company is doing

Olympus Medical Systems Corporation issued Urgent Medical Device Correction Letter on November 20, 2023. Letter states reason for recall, health risk and action to take: Olympus requires you to take the following actions: During an evaluation of user implementation of the Instructions for Use related to the reprocessing of the LTF-S190-5 videoscope, Olympus observed deviations from the following reprocessing steps detailed in the respective Reprocessing Manual Instructions. These steps are required for the proper reprocessing of these videoscopes. Therefore, Olympus is reminding users that following the instructions in these reprocessing manuals (LTF-S190-5 Reprocessing Manual, GE9382, and LTF-S190-10 Reprocessing Manual, RC0686) is required. Olympus is offering educational on-site support to review and train on the reprocessing instructions for the LTF-S190-5 and LTF-S190-10. The LTF-S190-10 is similar in design to the LTF-S190-5 and is therefore included in this corrective action 1. Carefully read the contents of this notification. 2. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the reprocessing instructions contained in Sections 5.5, 5.6, and 5.7 of the LTF Reprocessing Manuals, especially adhering to the immersion time for the entire endoscope, and the brushing or wiping steps. 3. If you have further distributed this product, forward this letter to those facilities immediately. 4. Olympus requests that you acknowledge receipt of this letter. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at [email protected] or by fax at 844-265-7383. For any questions about the acknowledgement form, please call the Sedgwick team at 844-483-3866. If you require additional information about the proper steps to reprocess, Olympus provides the following resources: Contact your local Olympus Endoscopy Support Specialist (ESS) or our Technical Assistance Center for assistance in ar

Recall details

Recall number
Z-0645-2024
Status
Open, Classified
Initiated by the company
Nov 20, 2023
Posted by the FDA
Jan 5, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
271 units US
Product code
HET
FDA submissions
K111425
Distribution
Nationwide

Product description

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 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 female reproductive organs.

Code information (models, lots, serial numbers)

UDI-DI: 04953170310386 All Serial Numbers

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93575).

Sources and updates

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