HUGO¿ RAS SYSTEM

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHILE SUTURING, THE BIPOLAR FENESTRATED GRASPER (BFG) INSTRUMENT BROKE. THE INSTRUMENT WAS NOT GRASPING TISSUE AND SNAPPED SHUT ON THE TISSUE. THE SURGEON LOST TELEOPERATION OF THE INSTRUMENT, AND THE BEDSIDE ASSISTANT ALSO LOST CONTROL. THE WHITE PART APPEARED TO BE BROKEN; HOWEVER, UPON INSPECTION, IT WAS FOUND TO BE INTACT. THE SURGEON USED ANOTHER INSTRUMENT TO REMOVE AS MUCH TISSUE AS POSSIBLE FROM THE JAWS, BUT A SMALL PIECE OF TISSUE REMAINED. THE INSTRUMENT WAS REMOVED AS A BROKEN INSTRUMENT AND REPLACED. THERE WAS NO PATIENT INJURY.