PILLCAM SB CAPSULE

Additional Manufacturer Narrative

THIS INCIDENT HAS BEEN PUBLISHED IN CASES JOURNAL, ACUTE SMALL BOWEL PERFORATION AFTER WIRELESS CAPSULE ENDOSCOPY IN A PATIENT WITH CROHN'S DISEASE: A CASE REPORT DHAVAN A PARIKHL*, JANAK A PARIKH, GREGORY C ALBERS AND CHARLES F CHANDLER. THE INVESTIGATORS CONCLUDED THAT: "WIRELESS CAPSULE ENDOSCOPY REMAINS THE PREFERRED ENDOSCOPIC IMAGING METHOD OF THE SMALL BOWEL. THIS CASE ILLUSTRATES THE IMPORTANCE OF APPROPRIATE PATIENT SELECTION AND EVALUATION OF FUNCTIONAL PATENCY OF THE SMALL BOWEL PRIOR TO WIRELESS CAPSULE ENDOSCOPY, ESPECIALLY WITH THE GROWING ROLE OF THIS PROCEDURE IN THE EVALUATION OF INFLAMMATORY BOWEL DISEASE."

Description of Event or Problem

AS REPORTED IN THE PUBLICATION: "A MALE PT WITH A PRESUMED QUIESCENT HISTORY OF CROHN'S DISEASE PRESENTED TO THE EMERGENCY DEPARTMENT IN A SEPTIC STATE 48 HOURS AFTER A WIRELESS CAPSULE ENDOSCOPY PROCEDURE COMPLAINING OF ABDOMINAL PAIN, DISTENSION, AND FREQUENT EMESIS. A COMPUTED TOMOGRAPHY SCAN OF THE ABDOMEN WAS SUGGESTIVE OF SMALL BOWEL PERFORATION AND ISCHEMIC ENTERITIS. THE PATIENT WAS ADEQUATELY RESUSCITATED AND TAKEN TO THE OPERATING ROOM FOR AN ILEOCECECTOMY AND EXTENSIVE RESECTION OF THE SMALL BOWEL. PATHOLOGY OF THE RESECTED SPECIMEN REVEALED AN ILEAL STRICTURE AND ASSOCIATED NECROTIZING ILEITIS, AND A PERFORATION JUST PROXIMAL TO THE STRICTURE."