PTEYE-1 FIBER OPTIC PROBE

Description of Event or Problem

THE SURGEON REPORTED THE PROBE APPEARED TO WORK APPROPRIATELY WHEN TAKING BASELINE MEASUREMENTS OF THE THYROID AND FOR ORIGINAL TEST READINGS OF THE THYROID. HOWEVER, UPON THE NEXT USE OF THE PROBE (APPROXIMATELY 6-8 MINUTES LATER) THE PROBE APPEARED TO BE DEFECTIVE, AS NO VARIABILITY IN READINGS WAS OBSERVED DESPITE APPLYING THE PROBE TO SEVERAL DIFFERENT STRUCTURES (THE SURGEON WAS UNABLE TO RECALL WHAT NUMBER APPEARED ON SCREEN). THE PROBE WAS DEEMED FAULTY AND A BACK-UP PROBE WAS ATTACHED TO THE SYSTEM. NEW BASELINE MEASUREMENTS WERE NOT TAKEN. THE NEW/REPLACEMENT PROBE OPERATED AS EXPECTED, WITH DIFFERENT NUMERICAL READINGS DISPLAYED WHEN THE PROBE WAS ACTIVATED ON DIFFERENT STRUCTURES WITHIN THE NECK. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

D10 - THE CONSOLE BEING USED WITH THE PROBE WAS PRODUCT ID - PTEYE PRODUCT DESCRIPTION - CONSOLE PTEYE SERIAL NUMBER - (B)(6). 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.

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.

Additional Manufacturer Narrative

UPDATED E3. 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.