FDA reports Urgent Field Safety Notice on mini PCNL sheath

Trokamed GmbH has updated the safety instructions for certain models of their mini percutaneous nephrolithotomy (PCNL) sheaths to clarify that the devices should not be used for suction and irrigation after 1 death was reported in relation to this issue.¹

There have been no device recalls associated with this alert.

An Urgent Field Safety Notice was issued to all affected health care professionals on November 26, 2024, and includes the following mini PCNL sheath models, with associated unique device identifiers (UDIs):

• Sheath, 20 Fr., 130 mm, WA2PS20S (UDI: 04251303810926)
• Sheath, 20 Fr., 160 mm, WA2PS20L (UDI: 04251303810919)
• Sheath, 18 Fr., 130 mm, WA2PS18S (UDI: 04251303810865)
• Sheath, 18 Fr., 160 mm,WA2PS18L (UDI: 04251303810872)

In the notice, the company urged customers to take 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’”

According to a news release from the FDA, “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.”

Previously, the instructions for use did not have this information clearly described. The reusable sheaths are intended to bring instruments, telescopes, and fluids to the surgical site during kidney stone surgery.

There have been no device recalls associated with this alert.

The agency noted, however, that they are “currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.”

The MAUDE report related to this issue was previously made available by the FDA.²

Health care professionals who experience an adverse reaction or quality issue related to these devices may contact MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

References

1. Early Alert: Nephroscope Sheath Issue from Trokamed GmbH. News release. US Food & Drug Administration. Published online and accessed December 20, 2024. https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-nephroscope-sheath-issue-trokamed-gmbh

2. MAUDE Adverse Event Report: TROKAMED GMBH MINI PCNL; NEPHROSCOPIC SHEATH. US Food & Drug Administration. Accessed December 20, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=19536211&pc=FED