FDA recalls Asensus - due to unintended arm motion

"A malfunction that could cause Asensus Surgical’s robotic system to move unexpectedly has received the most serious classification from the FDA.

The company’s laparoscopic Senhance system, with its multiple independent robotic arms, carries clearances for minimally invasive general surgery as well as gynecological procedures alongside its machine-vision-powered camera software.

According to the FDA, the platform’s laparoscope instrument actuator could potentially begin rotating continuously after being disconnected from its digital teleoperation remote control systems. Asensus sent a letter to its customers Sept. 15 alerting them to the issue and urging them to stop using Senhance until the company could deliver a software update."

"The Food and Drug Administration (FDA) deemed a recall of the Asensus Surgical 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."

 

Source: Fierce Biotech, The Robot Report