Devices

FDA Alert on Olympus Ligating Device Instructions

FDA has issued a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop, warning that improper use could lead to serious injury or death. The alert directs clinicians to follow newly reinforced instructions and supplemental safety guidance.

Olympus notified customers of the changes in a letter sent last month. The PolyLoop device is used with Olympus endoscopes to tighten a nylon loop around pedunculated polyps to prevent or control bleeding after polypectomy, according to the alert.

Olympus says it has received multiple complaints that the ligation loop could not be released or detached during procedures, causing it to become anchored around patient tissue. A preliminary investigation found two primary causes:

Accidental or intentional movement of the device’s yellow tube joint during use, which can prematurely tighten the loop and prevent release.
Forcefully advancing the slider on the handle when resistance is encountered, which can also prevent loop release.

When the loop becomes stuck, clinicians may be forced to perform emergency interventions, the alert says. Standard removal method, such as pliers, wire cutters, or the Olympus loop cutter, typically carry lower risks, including bleeding or minor procedural delays, it says. But using unapproved techniques outside the instructions for use can significantly increase dangers, including severe tissue injury, perforation, major bleeding, surgical intervention, or longer hospital stays.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome