The FDA deemed a recall of the Asensus Surgical (NYSE:ASXC) Senhance surgical robot as Class I, the most serious kind.
Asensus recalled its Senhance system due to malfunctions causing unintended movement of the robotically-assisted surgical device. The issue presented itself as an uncontrolled arm motion of the laparoscope instrument actuator (LI). In this case, the LIA rotated continuously in one direction after the surgeon removed the engagement of teleoperation on the system.
The company designed Senhance with emergency stop capabilities to stop this issue if observed. Asensus reported no patient impact or harm due to this issue to date. However, the potential for critical tissue trauma remains possible.
Affected Senhance systems include catalog numbers X9007708, X9007696 and X9007707. The recall affects five devices in the U.S., distributed between April 13, 2023, and Sept. 7, 2023. Asensus initiated the recall on Sept. 15, 2023, according to an FDA notice.
The company instructed affected customers to cease use of Senhance until the team updated the device’s software to version 2.7.5.
Asensus designed Senhance for use in general laparoscopic and laparoscopic gynecological procedures. The company won FDA clearance for the system in 2017. Since then, it secured expanded indications, deals with Google and Nvidia, and hospital placements in Japan, Germany, Switzerland and Russia.
Senhance became the first and only digital laparoscopic surgery system for children when the FDA cleared its pediatric indication in March.
The system’s 3 mm instruments are the world’s smallest among surgical robotics platforms — and those instruments are reusable. Asensus also designed Senhance with a 5 mm camera scope, haptic feedback, eye-tracking camera control and 3D visualization. The system uses machine learning and augmented reality to assist surgeons during procedures.