OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light s

FDA device recall Z-0644-2024 · posted 2024-01-05 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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

Action taken

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

Root cause

Labeling Change Control

Status

Open, Classified

Product code

HET

Quantity affected

1403 units US

Distribution

Nationwide

Date initiated

2023-11-20

Date posted

2024-01-05

Location

Center Valley, PA

Related 510(k) clearances