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’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 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.