MetaMedical™ Solutions Inc

FDA label Asensus Surgical robotic surgery device recall as Class I recall

US-based medical device company Asensus Surgical formerly TransEnterix has recalled its Senhance Surgical System due to involuntary movements of its robotically assisted surgical device.

This issue resulted in an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) meaning the LIA rotated endlessly in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. The device does have a built-in failsafe to perform an emergency stop if this occurs.

The recalled device was designed for laparoscopic surgical procedures and laparoscopic gynaecological surgery. It uses reusable instruments and an open-platform architecture strategy that allows hospitals to use existing technology. The company also claims it reduces time and cost-per-procedure when compared to manual laparoscopy.

According to GlobalData in the US 4.4 million laparoscopic procedures are performed annually. But, it can’t clarify if this number includes all types of laparoscopic surgical procedures or if it refers to a specific subset of procedures.

The US Food and Drug Administration (FDA) has identified the recall as a class I recall meaning it has a high risk of causing death or serious injury.

As of now, there have been no reports of harm caused to patients from the malfunction but the risk for critical tissue trauma is a concern.

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By GlobalData

On September 15, 2023, Asensus Surgical issued an Urgent Medical Device Recall to affected customers. The letter urged them to cease using the Senhance Surgical System until the device’s software is updated to version 2.7.5. and to return the device.

On November 13 2023 Asensus Surgical entered into an agreement with Flex which would help with the design and manufacturing of their LUNA Surgical System a digital surgery platform.

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