Early Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
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 as a result of a potentially high-risk device issue:
- 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”
- Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Early 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.
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.
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