Olympus issues class I recall for insufflation unit after '10 serious injuries, one death'
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Key takeaways:
- Olympus Medical’s recall of high-flow insufflation unit linked to 21 malfunctions, 10 serious injuries and one death.
- The FDA has designated this recall as class I.
The FDA has classified Olympus Medical’s recall of its high-flow abdominal insufflation device as class I, following reports of 21 malfunctions, 10 serious injuries and one death associated with over-inflation.
Olympus Medical’s High-Flow Insufflation Unit, model UHI-4, is intended to inflate the abdomen or colon with carbon dioxide gas during laparoscopic or endoscopic surgeries, including minimally invasive abdominal surgeries, colonoscopies or vein harvesting, according to the company.
Olympus initiated a recall of its UHI-4 insufflation device following reports of patient complications that may have resulted from over-insufflation of the abdominal cavity, including arrythmias reported as short cardiac arrests, gas embolism and one death during surgical procedures in which the devices were used.
“The use of the affected unit may cause serious adverse health consequences, including air embolism, and arrythmias including bradycardia, asystole or cardiac arrest,” the FDA alert stated. “Other risks include collapsed lung, kidney or urinary problems, oxygen cut off to organs and air trapped under the skin. Other necessary or complex medical procedures may be delayed because of over-insufflation, and death may occur.”
There are currently 21 malfunctions, 10 serious injuries, and one death, the alert reported. The recall includes 3,136 devices in the United States, which were distributed from May 29, 2012, to August 17, 2023, according to the FDA.
On Oct. 25, 2023, Olympus Medical sent its U.S. customers a field corrective action letter, requesting that they discontinue use of the unit until further notice unless they could not find an alternative. The company recommended the unit be quarantined and be appropriately marked/tagged to prevent its use.
In a company release, Olympus stated it would provide users with additional information to “weigh the potential benefits of the procedure vs. the potential risk of over insufflation, including identification of subpopulations more susceptible to risks, if an alternative device is not available for use.” Additionally, Olympus urged users to be extremely cautious if they needed to use the unit in the event that no alternative devices were available.
Reference:
- Olympus Issues Request to Discontinue Use of UHI-4 Insufflator Unit, Except in Cases Where No Alternative is Available. https://medical.olympusamerica.com/articles/olympus-issues-request-discontinue-use-uhi-4-insufflator-unit-except-cases-where-no Published Oct. 27, 2023. Accessed Oct. 30, 2023.
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