ENDOFLIP

Additional Manufacturer Narrative

THE CATHETER WAS CONNECTED TO THE ENDOFLIP UNIT AND AN EXPIRED CATHETER ERROR APPEARED. UPON EVALUATION, ANY CATHETER UTILIZED ON THE EF-100 SYSTEM FOLLOWING JANUARY 1, 2026 WILL BE INCORRECTLY FLAGGED AS EXPIRED DUE TO THE SYSTEM¿S 24-HOUR USAGE LIMIT, RENDERING THE CATHETER UNAVAILABLE FOR CLINICAL PROCEDURES. THE REAL TIME CLOCK WAS SET UP WITH A BASE YEAR OF 2010 AND WILL NOT SUPPORT CATHETERS AFTER 2025. D10 CONCOMITANT PRODUCT: EF-322N, ENDO CATHETER EF-322N 16CM NASAL TIP (LOT# 26A0487JZ); EF-322N, ENDO CATHETER EF-322N 16CM NASAL TIP (LOT# 26A1519JZ). THE REGULATORY REPORT 8020893-2026-00091 WAS INCORRECTLY SUBMITTED. ANY UPDATE TO THE EVENT WILL BE SUBMITTED IN THIS REPORT. 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 TWO CATHETERS FAILED PRECHECK-USE. PRECHECK WAS REPEATED THREE TIMES. THERE WAS NO PATIENT OR USER HARM.