Trokamed Updates Nephroscope Sheath Instructions for UseTrokamed Updates Nephroscope Sheath Instructions for Use

Trokamed GmbH recently issued an Urgent Field Safety Notice for its Mini PCNL Sheath after receiving information indicating increased device risk and, in turn, have updated its instructions for use (IFU).

The Mini PCNL Sheath is an endoscope sheath that is part of a nephroscopy accessory set intended for procedures like examining kidneys and removing kidney stones or other blockages. The sheath is a reusable, surgically invasive device for short-term use, according to FDA. It is designed to bring instruments, telescopes, and fluids to the surgical site.

Trokamed sent an early alert to customers on Nov. 26, stating that the IFU has been updated to make clear that the sheath is not to be used for suction and irrigation. The company noted that previous instruction iterations did not clearly describe that the device shouldn’t be used in this way.

If the sheath 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 go kidney rupture,” according to the notice.

One death has been reported as associated to the issue.

The company is recommending all affected customers 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, and to replace the existing IFU with the updated version dated 2024-11-27.

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Additionally, FDA said it is “currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.”