| Date Initiated by Firm |
September 22, 2023 |
| Date Posted |
October 18, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0075-2024 |
| Recall Event ID |
92932 |
| 510(K)Number |
K110294 K122180
|
| Product Classification |
Insufflator, laparoscopic - Product Code HIF
|
| Product |
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. |
| Code Information |
UDI-DI: 04953170324147;
All Serial Numbers |
Recalling Firm/
Manufacturer |
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
|
| For Additional Information Contact |
Cynthia Ow
484-896-5000
|
Manufacturer Reason
for Recall |
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 Determined
Cause 2 |
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 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 |
| Quantity in Commerce |
3136 units |
| Distribution |
US Nationwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = HIF and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
|
