—#202296

Product

The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5

FDA product code: FEB — Accessories, Cleaning, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K103264
Affected lot / code info: UDI-DI: 04953170355929. All lot numbers

Why it was recalled

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Olympus issued Urgent Medical Device Field Corrective Action letter on July 12,2023. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital and include a copy of this letter and addendum with any of these devices remaining in inventory. 2. Carefully read the content of this Medical Device Field Corrective Action as well as the attached Addendum for valve inspection instructions and updated MAJ-1444 reprocessing instructions: Disinfect the MAJ-1444 in the OER by placing the MAJ-1444 individually in the washing case of the endoscope reprocessor, with no other accessories. Note: Steam sterilization (autoclaving) or manual high-level disinfection remain available options per the existing instruction for use. 3. Ensure all personnel are informed on valve inspection requirements and to cease use and dispose of any valves suspected of having an abnormality. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0428 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Actions to be taken by the company: Olympus is updating the MAJ-1444 Instructions for Use to reflect the information found in the attached addendum. MAJ-1444 valves will be shipped with the Addendum until the Instructions for Use are updated. Olympus requests that you report complaints, including any injuries associated with the use of MAJ-1444, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). For additional support concerning this matter, please contact Tara Safi, Field Corrective Actions Administrator, at Tara.Safi@Olympus.com.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-07-12
Posted by FDA: 2023-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202296. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.