Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.
The US Food and Drug Administration (FDA) issued a medical device recall early alert, stating Olympus has issued a letter notifying affected customers that certain PolyLoop single-use ligating devices have updated use instructions.
According to the FDA, Olympus received complaints of the ligation loop not releasing or detaching as expected during use, causing it to become unintentionally anchored in place. An unreleased ligation loop presents procedural challenges as emergency intervention may be required to remove the device from the patient, and the method used for removal significantly influences the severity of these risks.
As of Oct 1, 2025, Olympus has reported 113 serious injuries and no deaths associated with this issue.
The PolyLoop single-use ligating device is designed to be used with an Olympus endoscope to deliver a nylon loop snare intended to prevent or control bleeding following a polypectomy of pedunculated polyps.
What to Do
On Nov 3, 2025, Olympus sent affected customers a letter recommending the following actions:
- Carefully read the contents of the letter, including the supplemental guidance and reinforced text from the instructions for use.
- Always have Olympus loop cutter available when using the PolyLoop device.
- When operating the yellow tube joint (yellow cylinder), be careful not to move it away from the handle, prematurely tightening the loop which may cause the inability to release the ligation loop.
- If resistance is encountered, do not continue or force the advancement of the slider located on the device handle.
- Maintain a straight position of the proximal end of the tube sheath to prevent increased frictional resistance which may lead to breakage of the operating pipe when the slider is pushed.
- Ensure all personnel are completely knowledgeable on the content of the notification. You may continue to use the device and are reminded of the importance of adhering to the warnings that are present in the instructions for use.
- Use of techniques not outlined in the instructions for use should be avoided unless emergency equipment listed within the indication for use is unsuccessful and/or unavailable.
- Acknowledge receipt of the letter through Olympus’ recall web portal.
- If you have further distributed this product, identify your customers and forward the notification to them.
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