Recall Z-0075-2024 ยท HIF Insufflator, Laparoscopic
Olympus Corporation of the Americas
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
| Date | Oct 18, 2023 (initiated Sep 22, 2023) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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 |
| Quantity | 3136 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |