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HIGH FLOW INSUFFLATION UNIT recallZ-0075-2024 · Olympus Corporation of the Americas · initiated Sep 22, 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

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT: MEDICAL DEVICE CORRECTIVE ACTION notification letter dated 9/22/23 was sent to customers. Action steps to be taken by the end user: Our records indicate that your facility has purchased one or more of the Olympus UHI-4. Olympus requires you to take the following actions: 1. Carefully read the content of this Field Corrective Action Letter. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter. 3. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at [email protected] or by fax at 866-367-6717. For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-4972. 4. If you have further distributed this product, identify your customers, and forward them this Letter. Please appropriately document your notification process and let us know the end-customer feedback accordingly. Olympus requests that you report complaints, including any injuries associated with over insufflation during the procedure with UHI-4, to Olympus. Please report complaints to Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. An URGENT: MEDICAL DEVICE CORRECTIVE ACTION - UPDATE notification letter dated 10/25/23 was sent to customers. Action steps to be taken by the end user: Our records indicate that your facility has purchased one or more of the Olympus UHI-4. Olympus requires you to take the following actions: 1. Inspect your inventory and identify any UHI-4 High flow insufflation unit(s). Quarantine and mark your units appropriately by your site to prevent usage. If your facility does not have alternatives or is unable to obtain alternatives, you may choose to use the UHI-4 while using extreme caution and after reviewing the information above

Recall details

Recall number
Z-0075-2024
Status
Open, Classified
Initiated by the company
Sep 22, 2023
Posted by the FDA
Oct 18, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
3136 units
Product code
HIF
FDA submissions
K110294, K122180
Distribution
US Nationwide distribution.

Product description

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Code information (models, lots, serial numbers)

UDI-DI: 04953170324147; All Serial 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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