SINGLE USE LIGATING DEVICE

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

DURING AN ATTEMPTED COLONOSCOPIC POLYPECTOMY OF A LARGE PEDUNCULATED SIGMOID COLON POLYP, A SINGLE-USE LIGATING DEVICE WAS USED TO LIGATE THE POLYP BASE. AFTER DEPLOYMENT, THE RELEASE MECHANISM FAILED, AND THE DEVICE COULD NOT BE RELEASED FROM THE LIGATED POLYP. THE DEVICE HANDLE WAS CUT, AND THE GUIDEWIRE WAS WITHDRAWN; HOWEVER, MULTIPLE ATTEMPTS TO TRANSECT THE RETAINED NYLON SNARE USING ENDOSCOPIC SCISSORS WERE UNSUCCESSFUL. ADDITIONAL INTERVENTIONS INCLUDED PLACEMENT OF FOUR TITANIUM CLIPS AND USE OF A DUAL KNIFE TO INCISE THE MUCOSA AROUND THE POLYP BASE. BLEEDING FROM THE BASE VESSELS SUBSEQUENTLY OCCURRED, RESULTING IN LOSS OF VISUALIZATION AND NECESSITATING TRANSFER TO THE OPERATING ROOM FOR EMERGENCY SURGERY. THE PATIENT UNDERWENT LAPAROSCOPIC ADHESIOLYSIS WITH CONVERSION TO AN OPEN PARTIAL SIGMOID COLECTOMY DUE TO PRIOR ABDOMINAL SURGERY AND INTRA-ABDOMINAL ADHESIONS, AND THE POSTOPERATIVE COURSE WAS REPORTED AS STABLE.