—#204880

Product

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.

FDA product code: HET — Laparoscope, Gynecologic (And Accessories)
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K111425
Affected lot / code info: UDI-DI: 04953170310386 All Serial Numbers

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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 Olympus3074@sedgwick.com 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

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2023-11-20
Posted by FDA: 2024-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.