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Recall Observatory FDA recall evidence

Device product

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

Z-0075-2024

September 22, 2023

Class I

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92932
Status
Ongoing
Classification
Class I
Quantity
3136 units
Official record key
device-enforcement:Z-0075-2024

Official wording

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.

Code information: UDI-DI: 04953170324147; All Serial Numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.