Olympus Updates PolyLoop Device Instructions After Serious Injury Reports

Olympus has revised the instructions for its PolyLoop ligation loop device, used with endoscopes to prevent or control bleeding, following reports of the loop becoming unintentionally anchored. The FDA classified the update as a Class I recall due to risks of severe tissue injury, bleeding, perforation, additional surgery, procedural delays, and hospitalization.

As of October 1, Olympus reported 113 serious injuries linked to loop release problems, with no deaths. The device is used to deliver a nylon snare during polyp removal procedures. Complaints noted the loop sometimes fails to release, potentially requiring emergency intervention. The FDA emphasized that following Olympus’ instructions—including using the Olympus loop cutter—generally limits risk to manageable bleeding and delays, while deviating from guidance increases danger.

Investigation found that movement of the yellow tube joint and forceful slider advancement can cause premature loop tightening. Olympus has faced multiple device safety issues in recent years and is implementing corrective measures under its new CEO.

08-12-2025