ESOFLIP

Description of Event or Problem

ACCORDING TO THE REPORTER, THE CATHETERS FAILED PRE CHECK AND MANUAL, THE DIAMETERS HOLD AT 8MM. THERE WAS NO PATIENT AND USER HARM.

Additional Manufacturer Narrative

H3: EVALUATION SUMMARY: FUNCTIONAL TESTING OF THE RETURN DEVICE CONFIRMED A MANUFACTURING FAULT. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY. A PROCESS IMPROVEMENT HAS BEEN INITIATED TO PREVENT THIS CONDITION FROM RECURRING. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.