Hugo™ Robotically Assisted Surgery (ras) System

Consumer Summary The Hugo Robotically Assisted Surgery System's Bipolar Fenestrated Graspers and Bipolar Maryland Forceps instruments are being recalled due to a manufacturing defect in the drive cable pulley assembly that can cause the instrument jaw to move incorrectly or uncontrollably during surgery, and may result in a small plastic component becoming loose inside the patient. This recall affects hospitals and surgical facilities in New Zealand that use these specific surgical instruments. The system is designed to stop controlling the affected instrument when this failure occurs.

Recalling firm

Medtronic New Zealand Limited

Product

Hugo™ Robotically Assisted Surgery (RAS) System. [Device]. Model: Bipolar Fenestrated Graspers; Bipolar Maryland Forceps. Also covers: Surgical Robotics - Bipolar electrosurgical device

Reason

Hugo™ robotic-assisted surgery (RAS) system Bipolar Fenestrated Graspers and Bipolar Maryland Forceps, Customer Facing Numbers MRASI0004 and MRASI0005 respectively, have been identified to have an increased likelihood of component failure within the instrument's drive cable pulley assembly due to manufacturing variations. When this failure occurs, the instrument jaw's actuation and articulation will be incorrect, uncontrolled motion may occur, and a visible small white plastic portion of the instrument's pulley component may become disengaged and loose within the patient's cavity. The...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-02-11

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/8ad3b0c0-10d5-4325-a26a-901e6d65c6bd