SITUATE

Additional Manufacturer Narrative

CORRECTION: B1, B2, H1 ADDITIONAL INFORMATION: G3 NEW INFORMATION HAS BEEN RECEIVED PERTAINING TO THE EVENT. THIS EVENT HAS BEEN REASSESSED AND THE REPORTABILITY HAS BEEN DETERMINED TO BE A SERIOUS INJURY. 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

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

ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ADRENALECTOMY. INITIALLY, THE RF MAT WAS UNINTENTIONALLY FOLDED DURING POSITIONING. AFTER THE CASE, THE MAT WAS USED BUT IT SHOWED DETECTION EVEN WHEN THE SPONGE COUNTS WERE CORRECT WITH RF MACHINE X18ASQ. A REPLACEMENT MACHINE WAS USED X18AOY WITH THE SAME MAT WHICH ALSO REVEALED DETECTION. THE STAFF USED THE WAND WHICH CLEARED THE COUNT BUT PER POLICY, AN X-RAY WAS TAKEN (NEGATIVE) WHICH DELAYED THE CASE. THE MAT WAS CHECKED WHICH RESULTED IN CLEAR READING. ON THE NEXT PROCEDURE WITH THE SAME PATIENT, PATIENT WAS ON SUPINE POSITION AND THE SAME MAT WAS USED. AFTER THE CASE, THE COUNT WAS CORRECT BUT WHEN THE MAT WAS USED, IT REVEALED DETECTION AGAIN. THE STAFF USED THE WAND TO VERIFY THE COUNT AND THE MACHINE X18AOY CLEARED THE READING. SPONGE, NEEDLE AND INSTRUMENT COUNTS WERE REPORTED TO BE CORRECT TWICE AND ALL RFA INTACT. EVENTUALLY, ONE OF THE MAT WAS MALFU NCTIONING WHICH HAD CLEAR DETECTION BUT THE OTHER(MAT) WAS POSITIVE. XRAYS WERE NEGATIVE FOR RETAINED FOREIGN BODY.

Description of Event or Problem

ACCORDING TO THE REPORTER, POST-OPERATIVELY ON LAP ADRENALECTOMY, INITIALLY, AN RF MACHINE WAS USED BUT THE RF MAT WAS UNINTENTIONALLY FOLDED DURING POSITIONING IN A CASE. AFTER THE CASE, THE MAT WAS USED BUT IT SHOWED DETECTION EVEN WHEN THE SPONGE COUNTS WERE CORRECT WITH RF MACHINE (SERIAL#: (B)(6)). A REPLACEMENT MACHINE WAS USED (SERIAL#: (B)(6) ) WITH THE SAME MAT WHICH ALSO REVEALED DETECTION. THE STAFF USED THE WAND WHICH CLEARED THE COUNT BUT PER POLICY, AN X-RAY WAS TAKEN WITH THE NEGATIVE RESULT WHICH DELAYED THE CASE.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: 01-0043, CONSOLE; MODEL 200X (SERIAL#:(B)(6) ); 01-0043, CONSOLE; MODEL 200X (SERIAL#: (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.