Question 1

Is OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter)
Model:  LTF-S190-5 

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.

 recalled?

Accepted Answer

Olympus Corporation of the Americas is recalling 1,674 ENDOEYE FLEX Deflectable Videoscopes (Models LTF-S190-5 and LTF-S190-10) because of deviations from the required reprocessing instructions. Proper cleaning and disinfection (reprocessing) are essential for these surgical tools, which are used in thoracic and abdominal surgeries. If the devices are not reprocessed exactly as required, there is a risk of contamination between patients. Consumers should contact their healthcare provider or the manufacturer to ensure their devices are being handled correctly.

Question 2

What should I do?

Accepted Answer

Identify if you have the affected OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE by checking the model number on the device: look for LTF-S190-5 (5.4 mm diameter) or LTF-S190-10 (10 mm diameter). Verify the UDI-DI on the product packaging: 04953170310355 for the 5.4 mm model or 04953170310386 for the 10 mm model. All serial numbers for these models are included in this recall. Immediately review your current reprocessing protocols against the most recent Reprocessing Manual Instructions provided by Olympus to ensure all required steps are being followed precisely. Contact Olympus Corporation of the Americas or your healthcare facility's equipment manager to confirm you have the correct Instructions for Use (IFU) and to discuss any necessary corrective actions. Healthcare providers should monitor patients who have undergone procedures with these devices if reprocessing deviations are suspected. For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or the manufacturer for further instructions and potential refund

Olympus Corporation of the Americas: ENDOEYE FLEX Deflectable Videoscopes Recalled Due to Reprocessing Errors

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

Were You Affected by This Recall?