Olympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations
Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for reprocessing instruction deviations on a videoscope used for internal endoscopic procedures. Improper sterilization of these devices poses a risk of patient harm through infection, even though no illnesses or injuries have been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 271 units of the OLYMPUS ENDOEYE Flex Deflectable Videoscope (Model LTF-S190-10), a 10 mm diameter endoscopic device distributed nationwide in the United States. The videoscope is used with ancillary equipment for endoscopy and endoscopic surgery in the thoracic and abdominal cavities, including female reproductive organs.
The recall addresses Instructions for Use-User Deviations related to the reprocessing of the videoscope. Proper reprocessing steps are required to ensure the device functions safely and effectively for clinical use. The manufacturer has detailed the required reprocessing procedures in the Reprocessing Manual Instructions.
Affected units are identified by UDI-DI: 04953170310386, with all serial numbers included in the recall. Users and healthcare facilities should refer to the corrected reprocessing instructions provided by Olympus to ensure proper sterilization and safe use of these devices.
The recalled product
- 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 t
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- improper-sterilization
- inadequate-instructions
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170310386 All Serial Numbers
Distribution
Distributed nationwide across the United States.
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