CENTER VALLEY, Pa., (October 27, 2023) – ÔÚÏߺÚÁÏÃÅCorporation 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, ÔÚÏߺÚÁÏÃÅrequests 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.
ÔÚÏߺÚÁÏÃÅis 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. ÔÚÏߺÚÁÏÃÅis:
- 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.
ÔÚÏߺÚÁÏÃÅis providing updated customer notifications, and ÔÚÏߺÚÁÏÃÅrepresentatives 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 ÔÚÏߺÚÁÏÃÅTechnical Assistance Center at 800-848-9024, Option 1 or email complaints@olympus.com.
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