MODULAR ELECTROMECHANICAL SURGICAL SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PARTIAL NEPHRECTOMY PROCEDURE, THE MONOPOLAR AND BIPOLAR INSTRUMENTS TOUCHED DURING ENERGY DELIVERY AND THE OPERATING ROOM TEAM INTERFACE (ORTI) IMAGE WENT BLACK. THE SYSTEM DID NOT DISPLAY ANY ERRORS. THE START-UP SPECIALIST (SUS) RESOLVED THE ISSUE BY UNPLUGGING AND REPLUGGING THE ENDOSCOPE DATA (VIDEO) CABLE. THE SURGEON CONTINUED USING THE SYSTEM. THERE WAS AN APPROXIMATELY 2¿3 MINUTE DELAY TO UNPLUG AND RECONNECT THE ENDOSCOPE. THERE WAS NO PATIENT INJURY.

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.