FDA issues alert on PCNL sheath safety after patient death

The U.S. Food and Drug administration (FDA) is making the public aware of an updated set of use instructions for Trokamed endoscope sheaths. The alert comes after the sheaths were used for suction and irrigation, resulting in the death of a patient. 

The Trokamed sheaths are typically used during minimally invasive procedures, including examining kidneys and removing kidney stones or other blockages. Updated use instructions have made it clear the sheaths are not to be used for suction or irrigation during procedures, as it could result in a life-threatening emergency due to blood, tissue and kidney stone fragments, which could reduce flow, cause a build up of fragments and potentially rupture a kidney. 

No products are being recalled as a result of this notice. 

What is being recalled?

Trokamed Mini PCNL Sheath
Trokamed Mini PCNL Sheath.

Trokamed’s Mini PCNL Sheath of all models are subject to the updated use instructions, including: 

  • Sheath, 20 Fr., 130 mm WA2PS20S
  • Sheath, 20 Fr., 160 mm WA2PS20L
  • Sheath, 18 Fr., 130 mm WA2PS18S
  • Sheath, 18 Fr., 160 mm WA2PS18L

Associated unique device identifiers (UDIs) are: 

  • 04251303810926
  • 04251303810919
  • 04251303810865
  • 04251303810872

Next Steps

Trokamed sent all affected customers an Urgent Field Safety Notice on Nov. 26, 2024. In addition to warning users about its Mini PCNL Sheaths for suction and irrigation, the company said surgeons must remove nephroscopes from the shaft and flush them to clear kidney stone fragments. 

Updated instructions should be placed with old supplies to ensure the devices are used safely.

For more, see the FDA notice here.

Chad Van Alstin Health Imaging Health Exec

Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.

Around the web

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 

The FDA recently cleared the company's cable-free, credit card-sized heart monitor that produces 12-lead ECGs.

If 25% tariffs go into effect, it could have a big impact on the cost of medical imaging and radiotherapy systems, with many manufacturing facilities in Mexico.