Device Name: TroCare TroKit Laparoscope Lens Wiper
Author(s): Nicolas Fuentes, M.D, David Pechman M.D
TroCare LLC. received FDA approval for TroKit Laparoscope Lens Wiper October 4th, 2024.
The TroKit Laparoscope Lens Wiper is a translucent single-use laparoscopic add-on device that fits and attaches to the distal end of a laparoscopic trocar to clean the camera lens from blood, tissue, fog, grease, and other surgical debris.
The lens wiper, a thermoplastic elastomer squeegee, is housed inside mechanical jaws and works automatically when the laparoscope is advanced through the trocar and can be used multiple times during surgery.
The device is indicated for robotic assisted intraabdominal surgeries, currently compatible with the DaVinci SI system and is intended to maintain the intra-operative view of the surgical field during minimally invasive surgery without the need to remove and clean the lens.
The TroKit passed evaluations for biocompatibility that assessment for cytotoxicity, sensitization, irritation, acute system toxicity, and material mediated pyrogenicity. In addition, non-clinical performance studies demonstrated that the device is safe to use and performs as intended.
No contraindications were documented.
FDA approve indications for use:
- Robotic surgery with DaVinci Si surgical system
Videos of use available at: https://www.trokitclean.com/the-solution