FDA
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia.
On December 28, 2020, the firm began notifying customers of the recall via Urgent Medical Device Correction letters. Customers were informed that serious injury could occur due to the failure mode associated with the correction.
Actions to be taken by the Customer:
Ensure proper removal of the Uni-Cot device by completely severing it from the digit, followed by verification that none of the device is remaining.
Actions being taken by Mar-Med:
Phase 1: Include a notice in each box of the device that identifies the risk for the users of this type of failure and provides specific guidance on how to avoid it.
Phase 2: Include a warning tag on the device. The warning tag will not release unless the device is completely removed from the digit.
Phase 3: In the near future an update will be made to the design of the device to better address usability and removal, maintaining the inclusion of the warning tag. An updated IFU will also be designed to provide clearer instructions and warnings.
Please contact Mar-Med with any questions or information about this type of failure at 616-454-3000 or at info@marmed.com.