CanadaHugo RAS Bipolar Maryland Forceps (model MRASI0005) and Hugo RAS Bipolar Fenestrated Grasper (model MRASI0004) with specific serial numbers (more than 10 numbers; contact the manufacturer for details) are affected. They were recalled because manufacturing variations can cause drive cable pulley assembly failure leading to incorrect jaw actuation, possible uncontrolled motion, and a small white plastic pulley component becoming disengaged and loose in the patient; the Hugo RAS system will detect this and halt telerobotic control. Contact the manufacturer for additional information.
What's being recalled
Companies: Covidien Llc, 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048.
How to identify it
Affected products: Hugo RAS Bipolar Maryland Forceps; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: MRASI0005
Affected products: Hugo RAS Bipolar Fenestrated Grasper; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: MRASI0004
The hazard
Medtronic is initiating a voluntary medical device field safety notice for specific serial numbers of the bipolar wristed instruments for the Hugo Robotic-Assisted Surgery (RAS) system. The instruments in scope 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 Hugo RAS system will detect this failure and halt telerobotic control of the affected instrument.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States