VALLEYLAB

Description of Event or Problem

IT WAS REPORTED THAT DURING CYSTOSCOPY AND BLADDER RESECTION PROCEDURE, THE MONOPOLAR FOOTSWITCH COAGULATION PEDAL WOULD NOT RELEASE WHEN SURGEON'S FOOT WAS REMOVED FROM DEPRESSING IT. THE FOOT PEDAL WHICH WAS ATTACHED TO THE MONOPOLAR RESECTING LOOP WAS STILL IN PATIENT'S BLADDER CONTINUED TO COAGULATE INSIDE THE PATIENT. SURGEON QUICKLY REALIZED WHAT OCCURRED AND REMOVED THE LOOP FROM THE PATIENT TISSUE. 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.