CENTER VALLEY, Pa., (October 27, 2023) – ³ÉÈËBÕ¾ Corporation has announced a field corrective action in the U.S. to address complaints of adverse events from over insufflation during use of the high-flow insufflation unit UHI-4.
In the field corrective action letter dated October 25, 2023, sent to U.S. customers, ³ÉÈËBÕ¾ requests discontinuing use of the device until further notice, except when an alternative is not available or cannot be obtained. Patient and healthcare provider safety, and mitigating any potential risks, are our top priorities.
³ÉÈËBÕ¾ is assessing the issue after receiving reports of patients suffering complications from over insufflation, including arrythmias reported as “short cardiac arrests,” gas embolism, and one death, during surgical procedures where UHI-4s were used. ³ÉÈËBÕ¾ is:
- Requesting that the device be quarantined and marked/tagged appropriately to prevent device use;
- Providing users with detailed information to weigh the potential benefits of the procedure versus the potential risk of over insufflation, including identification of subpopulations more susceptible to risks, if an alternative device is not available for use; and
- Recommending users exercise extreme caution if alternative devices are not available and they must use the device.
³ÉÈËBÕ¾ is providing updated customer notifications, and ³ÉÈËBÕ¾ representatives can assist in providing a list of alternative devices which may help facilities determine a suitable alternative device.
The UHI-4 is intended to facilitate laparoscopic and endoscopic observation, diagnosis and treatment. It is used to insufflate the abdominal cavity and colon and provides automatic suction and smoke evacuation.
Adverse reactions or quality problems experienced with the use of the product may be reported to the FDA’s MedWatch program online: .
For information or to report a problem, please contact the ³ÉÈËBÕ¾ Technical Assistance Center at 800-848-9024, Option 1 or email complaints@olympus.com.
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