Asensus Surgical Recalls Senhance Surgical System

Class I Recall Notice  

Asensus Surgical Inc. has announced a recall for its Senhance Surgical System due to malfunctions leading to unintended movement of the robotically-assisted surgical device. 

Device Use  

The Senhance Surgical System is a vital tool utilized in general laparoscopic surgical procedures and laparoscopic gynecological surgery. Designed for use by trained physicians in operating room environments, this system facilitates minimally invasive procedures in patients aged two (2) years and older, weighing 10kg or more, who are suitable for conventional endoscopic techniques. 

Reason for Recall  

The recall has been initiated due to malfunctions within the Senhance Surgical System, resulting in unintended movement of the robotically-assisted surgical device. Specifically, an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) has been observed, with the LIA rotating continuously in one direction after the surgeon disengages teleoperation on the Senhance System. While the system is equipped with emergency stop capabilities to address such issues, the potential for critical tissue trauma remains a concern. 

Who May be Affected  

Patients undergoing general laparoscopic surgical procedures and laparoscopic gynecological surgery are directly impacted by this recall. The risk is heightened for those requiring emergency laparotomy during minimally invasive procedures, with greater morbidity compared to uncomplicated procedures. Additionally, medical professionals relying on the Senhance Surgical System to assist in laparoscopic procedures must take immediate action in response to this recall. 

Recommended Actions  

Asensus Surgical Inc. has taken proactive measures to address the issue, urging affected customers to cease the use of the Senhance Surgical System until the device’s software is updated to version 2.7.5 by the Asensus Service Team. Furthermore, customers are requested to sign the “Acknowledgement of Receipt” document enclosed in the Urgent Medical Device Recall letter and return it promptly to Asensus Surgical. 

Conclusion 

The recall for the Senhance Surgical System underscores the paramount importance of patient safety and the need for swift action in addressing potential risks associated with medical devices.  

By adhering to the recommended actions outlined by Asensus Surgical Inc., healthcare providers can mitigate the potential for adverse outcomes and ensure the well-being of patients undergoing surgical procedures with the device.  

Links 

Read the recall notice here.