This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. The affected products and recommendations below have not changed.
Affected Product
The FDA is aware that Trokamed has issued a letter to affected health care providers indicating certain endoscope sheaths have updated use instructions:
- Mini PCNL Sheath
- All lots of the following Mini PCNL Sheath models:
| Description | Trokamed REF Number | UDI |
|---|---|---|
| Sheath, 20 Fr., 130 mm | WA2PS20S | 04251303810926 |
| Sheath, 20 Fr., 160 mm | WA2PS20L | 04251303810919 |
| Sheath, 18 Fr., 130 mm | WA2PS18S | 04251303810865 |
| Sheath, 18 Fr., 160 mm | WA2PS18L | 04251303810872 |
What to Do
- On November 26, 2024, Trokamed sent all affected customers an Urgent Field Safety Notice recommending the following actions:
- Do not use the Mini PCNL sheath as a suction and irrigation device.
- Temporarily remove the nephroscope from the shaft to clear it and flush out kidney stone fragments.
- Replace the instructions for use with the updated version provided by Trokamed and dated “2024-11-27”
Reason for Alert
The previous instructions for use provided with the device did not clearly describe that the sheath is not to be used for suction and irrigation. If the device is used for suction or irrigation, it could result in reduced outflow through the shaft due to blood, tissue, and kidney stone fragments, which may quickly build up pressure within the kidney that may lead to kidney rupture.
Trokamed has reported 1 death associated with this issue.
Device Use
The Mini PCNL Sheath is part of a nephroscopy accessory set intended for minimally invasive procedures, including examining kidneys and removing kidney stones or other blockages. The sheath is a reusable, surgically invasive device for short-term use. It is designed to bring instruments, telescopes, and fluids to the surgical site.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Trokamed at k.troendle@trokamed.de or +49 770492440.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
