UNKNOWN LAP SPONGE

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 AFTER A ROBOTIC SALPINGECTOMY, UPON COMPLETION OF THE PROCEDURE THE NURSE USED THE SITUATE AND SCANNED THE PATIENT. THE SYSTEM ALERTED THAT A SPONGE WAS LEFT INSIDE THE PATIENT. THE NURSE SCANNED AFTER THE SURGEON CLOSED THE PATIENT UP. THE SPONGE IS STILL IN THE PATIENT AND THE PATIENT WAS NOTIFIED THAT THE SPONGE WAS STILL INSIDE THEM. PATIENT OPTED TO NOT GOING BACK INTO SURGERY TO GET IT REMOVED.