FDA Issues Alert on Mini PCNL Sheath Safety Risks

FDA Issues Alert on Mini PCNL Sheath Safety Risks

Introduction

Healthcare providers are being cautioned against using Trokamed Nephroscope Mini PCNL Sheaths for specific procedures due to risks of severe patient injuries, including kidney ruptures and at least one reported death.

FDA's early alert

On December 20, the U.S. Food and Drug Administration (FDA) issued an early alert about the devices following multiple adverse event reports. These sheaths are part of nephroscope sets used in minimally invasive kidney procedures, such as removing kidney stones or blockages. They facilitate the introduction of surgical tools, telescopes, and fluids to the site. However, misuse or design flaws can result in critical complications.

The FDA’s early alert is part of a new pilot program aimed at warning the public about potentially hazardous medical devices before an official recall is initiated. This proactive measure is intended to reduce the risk of injuries and fatalities.

Urgent Field Safety Notice

The alert follows a November 26 Urgent Field Safety Notice from Trokamed, which identified safety concerns with specific endoscope sheaths. The notice clarified that the devices should not be used for suction or irrigation procedures, a point not clearly stated in earlier guidelines. Using the sheaths for such purposes can lead to blockages caused by blood, tissue, or kidney stone fragments, reducing outflow and causing dangerous pressure buildup in the kidney. This pressure can lead to kidney rupture, which has already resulted in one reported fatality.

Removal of nephroscope from the sheath

To mitigate risks, Trokamed recommends that healthcare providers periodically remove the nephroscope from the sheath to clear obstructions and flush out fragments, thereby preventing pressure buildup. Updated usage instructions have been issued, dated November 27, 2024.

List of affected products

Affected products include the Sheath 20 Fr (130 mm and 160 mm) and Sheath 18 Fr (130 mm and 160 mm) with Trokamed reference numbers WA2PS20S, WA2PS20L, WA2PS18S, and WA2PS18L.

The FDA is currently investigating these high-risk devices and will provide further updates as additional information becomes available or if a formal recall is initiated. In the meantime, healthcare professionals are urged to exercise caution and adhere strictly to the revised guidelines to protect patient safety.