Asensus Surgical has recalled 21 units of the Senhance Surgical System, a robotic surgical platform, due to a malfunction involving uncontrolled robotic arm motion. In some instances, the Laparoscope Instrument Actuator (LIA) rotated continuously in one direction after the surgeon had already disengaged the system's teleoperation controls. This movement is unexpected and happens when the system is supposed to be stationary, which could lead to surgical complications. These units were distributed across several states and international locations including Germany, Japan, and Lithuania.
The robotic arm can move without surgeon input, potentially causing unintended contact or injury to a patient during a procedure. No other robotic arm components were observed to move uncontrollably during these reported incidents.
Manufacturer initiated recall notification via letter.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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