ITIND, WITH SNARE, STERILE

Description of Event or Problem

IT WAS REPORTED THAT DURING THE REMOVAL OF THE SUBJECT DEVICE; THE PHYSICIAN UTILIZED A COOK FLEXOR PARALLEL ACCESS SHEATH. DUE TO ITS DESIGN, THE SHEATH CUT THE SUTURE AT THE HUB OF THE SUBJECT DEVICE. REPORTEDLY, THE PROCEDURE WAS PROLONGED BY AT LEAST OR GREATER THAN 30 MINUTES. AS A RESULT, THE PATIENT WAS MOVED TO THE OPERATING ROOM FOR SEDATION, AND THE DEVICE WAS SUCCESSFULLY REMOVED USING A CYSTOSCOPE SHEATH AND GRASPER. THERE WERE NO REPORTS OF FURTHER PATIENT IMPACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY OLYMPUS, BUT NO FURTHER INFORMATION WAS RECEIVED AT THIS TIME.