The US Food and Drug Administration (FDA) has designated a recall of Olympus’ High Flow Insufflation Units as Class I.
A Class I recall indicates that continued use of the device with model number UHI-4 may cause serious injury or death.
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According to a 30 October FDA notice, there have been 21 malfunctions, ten serious injuries, and one death.
The recall relates to issues of the units over-inflating air into the body without warning. The FDA said that air embolism and cardiac arrhythmias are amongst the potential health consequences of the malfunctioning devices.
The agency highlighted this recall is a correction, not a product removal.
Olympus initiated the recall in August 2023, with 3,136 devices distributed between May 2012 and August 2023 having been recalled in the US.
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By GlobalDataThe device uses carbon dioxide to inflate the abdomen or colon during laparoscopic or endoscopic surgeries.
In a statement, Olympus stated it had issued a field corrective action letter on 25 October 2023 to US customers. The Japanese company said that use of the device should be discontinued except where an alternative is not available.
Olympus stated: “Olympus is assessing the issue after receiving reports of patients suffering complications from over-insufflation, including arrhythmias reported as ‘short cardiac arrests’, gas embolism, and one death, during surgical procedures where UHI-4s were used.”
Olympus has already faced FDA scrutinisation recently. The company, along with its subsidiary Aizu Olympus, received a warning letter from the FDA after an inspection in November 2022 found shortcomings in compliance over endoscope manufacturing.
