ENDOFLIP

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ALARM ON THE SCREEN STATING "A USAGE LIMIT HAS BEEN REACHED FOR THIS CATHETER. YOU MUST REPLACE IT WITH A NEW CATHETER TO BEGIN A NEW PROCEDURE". THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: EF-322N, ENDO CATHETER EF-322N 16CM NASAL TIP (LOT#25J1313JZ). 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.