Medtronic Recalls Bipolar Hugo RAS System Instruments Due to Component Failure Risk

What Happened

Medtronic (Covidien Llc) is initiating a voluntary medical device field safety notice for specific serial numbers of bipolar wristed instruments used with the Hugo Robotic-Assisted Surgery (RAS) system. The company identified an increased likelihood of component failure within the instrument’s drive cable pulley assembly due to manufacturing variations. When a failure occurs, the instrument jaw’s actuation and articulation become incorrect, potentially leading to uncontrolled motion. Additionally, a small white plastic portion of the pulley component may disengage and become loose within the patient’s cavity.

Which Products Are Affected

The recall affects specific serial numbers for the following models:

• Hugo RAS Bipolar Maryland Forceps: Model/Catalogue Number MRASI0005
• Hugo RAS Bipolar Fenestrated Grasper: Model/Catalogue Number MRASI0004

There are more than 10 affected serial numbers. Facilities are advised to contact the manufacturer to verify if their specific units are included in this notice.

What You Should Do

The Hugo RAS system is designed to detect this specific failure and will automatically halt telerobotic control of the affected instrument if the issue is identified. Healthcare providers and facilities using these instruments should contact the manufacturer, Covidien Llc (Medtronic), for further instructions and to confirm affected serial numbers. The company is located at 15 Hampshire Street, Mansfield, Massachusetts, 02048.

Why This Matters

This recall is critical because component failure during robotic surgery can lead to uncontrolled instrument movement and the introduction of foreign plastic debris into a patient’s body cavity, posing serious safety risks during surgical procedures.

Source

Health Canada