FDA Issues Trokamed Nephroscope Sheath Kidney Rupture Warning After Patient Death

Healthcare professionals are being urged not to use Trokamed Nephroscope Sheaths for certain procedures, due to a risk that the devices may cause serious injuries for patients.

The U.S. Food and Drug Administration (FDA) issued an early alert for the Trokamed Nephroscope Mini PCNL Sheaths on December 20, following multiple reports of kidney ruptures, severe injuries, and at least one death linked to the devices.

The nephroscope mini sheath is part of a nephroscope set used for minimally invasive procedures, such as examining kidneys and removing kidney stones or other kidney blockages. It is designed to bring surgical instruments, telescopes and fluids to the area undergoing surgery.

The FDA early alert is part of a pilot program recently implemented by the agency to warn the public about dangerous risks associated with medical devices before an official recall is announced.

When the agency becomes aware of a potentially high-risk device that may cause injuries to patients, the FDA will now alert the public in advance of an official recall. This effort is meant to help prevent unnecessary injuries and deaths.

The FDA warning followed an Urgent Field Safety Notice issued by Trokamed on November 26, which alerted healthcare providers to high-risk issues with certain endoscope sheaths. The notice included updated instructions clarifying that the devices should not be used for suction and irrigation procedures, a detail that was unclear in the original guidelines.

Using the sheathes for suction or irrigation may lead to reduced outflow through the shaft of the sheath due to blood, tissue and kidney stone fragments becoming lodged within it, the FDA and manufacturer warn. This can also cause pressure to build up quickly within the kidney, leading to a risk of kidney ruptures.

One death has been reported in connection to the sheath problem after a patient suffered a kidney rupture.

The manufacturer also recommends medical providers temporarily remove the nephroscope from the shaft to clear it and flush out kidney stone fragments to help prevent pressure from building up. Additionally, Trokamed issued replacement instructions for use with the updated version dated “2024-11-27.”

Devices affected by the early alert warning include: 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.

Affected devices include those with unique device identifiers:

• 04251303810926
• 04251303810919
• 04251303810865
• 04251303810872

The FDA is currently investigating the high-risk Trokamed Nephroscope Sheath device issue and will continue to keep the public informed as new information becomes available and if an official recall is issued.

Customers can contact Trokamed with questions about problems with the devices at k.troendle@trokamed.de or +49 770-49-2440. Reactions, side effects and other problems experienced in connection with the device should be reported to the FDA’s MedWatch Adverse Event Reporting Program.