SITUATE

Description of Event or Problem

IT WAS REPORTED THAT AFTER PROCEDURE, A PATIENT RETURNED TO THE OPERATING ROOM WITH AN INFECTION FOLLOWING A SURGICAL PROCEDURE IN WHICH AN X-RAY, RFD 4X4 GAUZE WAS UTILIZED. A RETAINED PORTION THAT FELL INTO THE PATIENT'S CAVITY OF THE DETECTION SPONGE, SPECIFICALLY THE DETECTION CHIP PORTION, WAS FOUND IN THE PATIENT'S CAVITY AND WAS NOT FULLY RETRIEVED DURING THE INITIAL PROCEDURE. THE PATIENT REQUIRED REOPERATION TO REMOVE THE RETAINED SPONGE PORTION. AFTER THE INITIAL SURGERY, THE PATIENT WAS SCANNED WITH A DETECTION SYSTEM, WHICH INDICATED THAT NO SPONGES WERE DETECTED, DESPITE THE PRESENCE OF THE RETAINED PORTION. AN X-RAY WAS CONDUCTED TO ASSIST IN LOCATING THE RETAINED PIECE. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION. A NEW SPONGE FROM SHELF TO CHECK WAND AND THE NEW SPONGE WORKED FINE. BOTH THE CONSOLE AND WAND WORKED FINE/SCANNED PROPERLY WHEN THEY SCANNED THE NEW SPONGE.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: 01-0043, CONSOLE; MODEL 200X, SERIAL (B)(6); 01-0046, 01-0046, BLAIR PORT WAND X (LOT#SW02869). 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.