—#206261

Product

Insufflation unit, UHI-4.

FDA product code: HIF — Insufflator, Laparoscopic
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K110294
Affected lot / code info: Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.

Why it was recalled

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

Root cause (FDA determination)

Process control

Action the firm took

On February 16, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE CORRECTIVE ACTION letters. Customers were informed of a new action regarding the UHI-4 front LED control panel. These units should have been quarantined from a previous October 25, 2023 notification related to an overpressure issue. Olympus will replace the CR board for UHI-4 older than 4.5 years. This repair of the CR board will not correct or address the overpressure issue which was the reason for the quarantine noted in our October 25, 2023, communication regarding the overpressure situation. In connection with the overpressure issue, Olympus has identified software mitigations that will aid in the prevention of over pressurization situations. Olympus will be communicating with you at the end of summer 2024 regarding this software update for the UHI-4 device. If you decided to continue using the UHI-4, Olympus recommends a compatible insufflator be readily accessible as a backup during procedures. Action steps to be taken by the customer 1. Olympus will contact you based on device age and parts availability to schedule a repair to replace the CR board. Olympus will also be prioritizing this action for customers who have to continue using the UHI-4 during the quarantine action. To ensure continuity of care, Olympus will make every effort to provide a loaner while the unit is sent to the Olympus Service Center. 2. Please acknowledge receipt of this letter and, if applicable, indicate which serial numbers are still in use by your facility. 3. If you have further distributed this product, forward this letter to those facilities. Please contact your local Sales Representative for support regarding alternatives to the UHI-4 should you no longer wish to keep your UHI-4. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, p

Recalling firm

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

Distribution

Distribution pattern: Domestic: Nationwide Distribution.

Timeline

Recall initiated: 2023-09-25
Posted by FDA: 2024-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206261. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.