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AIR/WATER VALVE recallZ-2447-2023 · Olympus Corporation of the Americas · initiated Jul 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected].

Recall details

Recall number
Z-2447-2023
Status
Open, Classified
Initiated by the company
Jul 12, 2023
Posted by the FDA
Aug 23, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
29590 units
Product code
FEB
FDA submissions
K103264
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 04953170355929. All lot numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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