Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Summary
The FDA issued a Class I for Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. by Olympus Corporation of the Americas. Reason: There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. Thes.
Details
Source
Device Recall
External ID
Z-0075-2024
Action Date
2023-10-25
Status
Ongoing
Category
device
Product Description
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Lot/Code Info: UDI-DI: 04953170324147; All Serial Numbers
Quantity Affected: 3136 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-22
Company
Center Valley, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 141 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0075-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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