The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product (Include the following information)
- Product Names: Asensus Senhance Surgical System
- Product Codes: See Recall Database Entry
- Catalog Numbers: X9007708, X9007696, and X9007707
- Distribution Dates: April 13, 2023 to September 7, 2023
- Devices Recalled in the U.S.: 5
- Date Initiated by Firm: September 15, 2023
The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use. Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.
Reason for Recall
Asensus Surgical Inc. is recalling the Senhance Surgical System due to malfunctions that cause unintended movement of the robotically-assisted surgical device. This issue presented itself as an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. The Senhance System is designed with emergency stop capabilities to stop this issue if observed.
There has been no patient impact or harm that has occurred due to this issue, however, the potential for critical tissue trauma is possible.
Who May be Affected
- People undergoing general laparoscopic surgical procedures and laparoscopic gynecological surgery.
- Those that require an emergency laparotomy during a minimally invasive procedure have greater morbidity compared to an uncomplicated procedure.
- Medical Professionals that use this device to assist in laparoscopic procedures.
What to Do
On September 15, 2023, Asensus Surgical Inc. sent all affected customers an Urgent Medical Device Recall letter.
The letter requested customers to:
- Stop use of the Senhance Surgical System until the Asensus Service Team has updated the device’s software to version 2.7.5.
- Sign the “Acknowledgement of Receipt” document, which was included in the letter, and return to Asensus Surgical.
Customers in the U.S. with questions about this recall should contact Asensus Surgical, Inc. at 1-888-879-4111.
Full List of Affected Devices (if applicable)
- The Senhance Surgical System with Software (SW) version 2.7.4.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.