The FDA is warning healthcare providers and consumers that Olympus’s August 9, 2023 recall of its Olympus High Flow Insufflation Unit has now been labeled Class I, the most serious type, because use of an uncorrected product could cause serious injuries or death.
Used to inflate the abdomen or colon with carbon dioxide gas, the Olympus High Flow Insufflation Unit is typically implemented during laparoscopic or endoscopic surgeries, which may include “minimally invasive abdominal surgeries, colonoscopies, or vein harvesting.” Other uses include automatic suction and smoke evacuation.
The August 9, 2023, which officials note is a correction and not a removal of the product, impacts 3,136 devices that were distributed across the U.S. between May 29, 2012 and August 17, 2023.
Olympus took action after it was determined that use of an affected unit could “over-insufflate,” or inflate an excess of air into the body without alerting its user. As a result, patients could suffer major adverse health outcomes that include air embolism and arrhythmias (disorders of the heart rate or rhythm) like “bradycardia, asystole, or cardiac arrest.” Individuals could also experience a “collapsed lung, kidney or urinary problems,” decreased oxygen supply to their organs, as well as air trapped under skin. Over-insufflation may also result in the delay of other crucial or complex medical procedures, putting patients in a life-threatening situation.
To date, Olympus has been made aware of 21 reports of device malfunctions, 10 reports of major injuries, and 1 report of death.
Those directly affected by the recall are identified as patients receiving treatments requiring insufflation. Officials say those most at risk are children, elderly people, and patients who have suffered cardiac arrhythmias or chronic respiratory disease.
An updated Urgent Medical Device Corrective Action Letter issued by Olympus on October 25 2023 requested that customers:
- Thoroughly read the Corrective Action Letter
- Review their inventory and identify any UHI-4 High flow insufflation units in their possession.
- Immediately cease all use of the units until
- an investigation is completed, and
- Olympus provides additional instructions.
- In the meantime, quarantine and carefully mark all affected units to prevent usage.
- In the event that no alternatives are available or obtainable, the UHI-4 may be used with “extreme caution,” carefully following the considerations put forth in the Letter.
- Be sure that all relevant personnel are thoroughly knowledgeable and trained with regards to the Letter’s contents.
- Complete and submit the enclose response form to Olympus’ recall partner, Sedgwick via email at Olympus5578@sedgwick.com. Faxes can also be sent at 866-367-6717. Sedgwick representatives may be reached at 855-215-4972 regarding questions about the form.
- Forward the Letter to all impacted customers/sub-distributors.
- Document and report and complaints or injuries related to over-insufflation to Olympus’ Technical Assistance Center by calling 1-800-848-9024, option 1.
Olympus encourages U.S. customers to direct any recall-related questions to the company at 1-800-848-9024, option 1.
As the FDA continues to monitor the recall, healthcare professionals and consumers are asked to report any related adverse events and quality issues to the agency’s MedWatch program.
If you have suffered an adverse health outcome that can be traced to the use of a defective and compromised medical device, we would like to help you fight for maximum compensation. Our compassionate attorneys at TruLaw work tirelessly to defend consumer safety standards and hold negligent parties accountable. To learn how we can support you in the next steps, connect with us online or try out our free Instant Case Evaluation ℠.