SITUATE

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE, DURING THE CLOSING COUNT THE SCRUB TECH AND CIRCULATOR NOTICED THAT A RAYTEC SPONGE WAS MISSING. THE SURGEON WAS MADE AWARE AND THE BODY SCANNER CONFIRMED THAT THE SPONGE WAS SOMEWHERE IN THE FIELD. AFTER NUMEROUS COUNTS AND A LOT OF SEARCHING THE STAFF DECIDED IT WOULD BE BEST TO GET AN X-RAY. THEY USED THE WAND SCANNER TO WAND THE GARBAGE BAGS AND THE PATIENTS' ABDOMEN/PERINEAL AREA. THE WAND DID NOT PICK UP THE SPONGE IN THE PATIENT'S RECTUM. THE X-RAY DID CONFIRM THAT THE SPONGE WAS IN THE PATIENT'S RECTUM. PHOTO OBSERVATION SHOWS CONSOLE WITH A RED DISPLAY WITH THE WORD DETECTION IN THE MIDDLE BUT THE WORD DETECTION WAS CROSSED OUT.

Additional Manufacturer Narrative

D10: CONCOMITANT PRODUCTS: 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.