—#202943

Product

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

FDA product code: HIF — Insufflator, Laparoscopic
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K110294, K122180
Affected lot / code info: UDI-DI: 04953170324147; All Serial Numbers

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 olympus5578@sedgwick.com 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

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: 2023-09-22
Posted by FDA: 2023-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202943. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.