Dive Brief:
- Olympus has updated the instructions for a device used with endoscopes to prevent or control bleeding, the Food and Drug Administration said Wednesday.
- As of Oct. 1, Olympus had reported 113 serious injuries and no deaths associated with problems releasing or detaching its PolyLoop ligation loop device, according to the FDA and its Australian counterpart.
- The FDA categorized the correction as a Class I recall because of the potential for the problems to result in severe tissue injury, bleeding, perforation, additional surgical intervention, extensive procedural delays and hospitalization.
Dive Insight:
Olympus wrote to customers in November to share the findings of an investigation into complaints about its PolyLoop device. Healthcare professionals use the ligation loop with an Olympus endoscope to deliver a nylon snare. The procedure prevents or controls bleeding following surgery to remove a type of polyp.
Some users complained that the ligation loop was unable to release or detach as expected during use. The unexpected behavior can cause the loop to become unintentionally anchored in place. Emergency intervention may be required to remove the device from the patient’s anatomy, the FDA said.
The risks associated with removal depend on the technique used. The PolyLoop instructions for use advise healthcare professionals to use an Olympus loop cutter to remove the anchored device. Following the instructions generally limits the risks to bleeding and minor procedural delays, which can typically be managed with endoscopic hemostasis clips, the FDA said. Diverging from the instructions raises the risks.
“If standard removal methods are unsuccessful or not attempted, and alternative techniques are used outside of the instructions for use guidance, the risks are significantly increased, and potential escalation to higher levels of care are possible,” the FDA said.
Olympus recommended that healthcare professionals always have its loop cutter available when using the PolyLoop. Healthcare professionals should avoid using techniques outside the approaches recommended in the instructions for use unless standard approaches are unsuccessful or unavailable.
The company’s preliminary investigation identified the movement of the yellow tube joint away from the device handle during use as a cause of the problem. Such movement can cause the PolyLoop to tighten prematurely and prevent the release of the ligation loop. Forceful advancement of a slider on the device handle when encountering resistance can also prevent loop release.
Olympus has faced a series of compliance, safety and quality problems in recent years, including injuries from endobronchial combustion and an FDA import block on certain devices. The company is working to fix the problems under a recently appointed CEO who is overseeing 2,000 job reductions globally.
