SITUATE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3, H6 (FDR) 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 DURING A SURGICAL PROCEDURE INVOLVING THE MITG RADIOFREQUENCY (RF) SURGICAL ACCESSORIES, A PIECE OR PART FELL INTO THE PATIENT'S CAVITY, WHICH WAS FULLY RETRIEVED AT THE END OF THE CASE WITHOUT THE NEED FOR AN X-RAY. THERE WAS NO ANOTHER PROCEDURE NEEDED TO REMOVE THE PIECE. ADDITIONALLY, A HOLE WAS DISCOVERED IN THE SPONGE WHEN IT WAS PULLED OUT OF THE SCROTAL SAC, PROMPTING THE SURGICAL TEAM TO SWITCH TO LAPS FOR THE REMAINDER OF THE CASE. THE GREEN SECTION OF THE SPONGE WAS FOUND WITH THE RFID TAG HANGING BY A THREAD, ABOUT TO DISLODGE. THE SURGICAL FIELD WAS SCANNED AND CLEARED AFTER THE FINAL COUNT. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.

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

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE MITG RADIOFREQUENCY (RF) SURGICAL ACCESSORIES, A PIECE OR PART FELL INTO THE PATIENT'S CAVITY, WHICH WAS FULLY RETRIEVED WITHOUT THE NEED FOR AN X-RAY. ADDITIONALLY, A HOLE WAS DISCOVERED IN THE SPONGE WHEN IT WAS PULLED OUT OF THE SCROTAL SAC, PROMPTING THE SURGICAL TEAM TO SWITCH TO LAPS FOR THE REMAINDER OF THE CASE. THE GREEN SECTION OF THE SPONGE WAS FOUND WITH THE RFID TAG HANGING BY A THREAD, ABOUT TO DISLODGE. THE SURGICAL FIELD WAS SCANNED AND CLEARED AFTER THE FINAL COUNT. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D3 (MFR NAME, STREET 1, MFR CITY AND MFR REGION), G3, PMA/510(K) #, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE SAMPLE WAS DAMAGED, AND THE RFID TAG FELL OUT. IT WAS REPORTED THAT A COMPONENT HAD DISENGAGED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.