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 RADICAL HYSTERECTOMY PROCEDURE, WHILE GRASPING THE LIGAMENT, THE JAWS OF THE BIPOLAR FENESTRATED GRASPER BROKE. THE BROKEN WHITE PLASTIC PIECE FELL INTO THE PATIENT¿S ABDOMINAL CAVITY AND WAS RETRIEVED LAPAROSCOPICALLY THROUGH THE CANNULA. THE INSTRUMENT WAS REPLACED WITH A NEW ONE, AND THE SURGERY PROCEEDED. THERE WAS NO PATIENT INJURY.