ORISE™ M00519510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729974604), received between Apr 24, 2018 and Aug 31, 2018 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE TISSUE RETRACTION SYSTEM WAS USED IN THE RECTAL/SIGMOID REGION OF THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE DEVICE WAS BEING USED TO RESECT A 4 CM FLATTER LESION THAT TESTED POSITIVE FOR HIGH-GRADE DYSPLASIA (HGD) ON BIOPSY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND PRIOR TO INSERTING THE ORISE DEVICE, A CIRCUMFERENTIAL MUCOSAL CUT WAS MADE AND APPROXIMATELY 30% OF THE LESION WAS DISSECTED USING TRADITIONAL ESD METHODS. THE ORISE DEVICE WAS THEN INSERTED TO VISUALIZE THE LESION AND WAS PUSHED THROUGH THE PORTION OF THE LESION THAT HAD BEEN DISSECTED, CAUSING A PERFORATION. REPORTEDLY, THE PHYSICIAN MAY HAVE "PUSHED TOO HARD" WHEN INSERTING THE DEVICE. THE PERFORATION WAS TREATED BY LAPAROSCOPICALLY PERFORMING A RECTAL SIGMOID RESECTION, REMOVING THE LESION AND THE PERFORATION, AND CONNECTING THE ANASTOMOSIS. THERE HAVE BEEN NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Bowel Perforation; No Code Available

  MAUDE report 7838696 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE TISSUE RETRACTOR WAS USED DURING A COLONOSCOPY WITH ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT HAD A LARGE POLYP IN THE SIGMOID COLON APPROXIMATELY 30 CM FROM THE ANUS, AND THE PATIENT HAD A HISTORY OF MICRO TEARS DURING PREVIOUS POLYPECTOMY PROCEDURES. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND PRIOR TO INSERTING THE ORISE TISSUE RETRACTOR, A CIRCUMFERENTIAL CUT WAS MADE AROUND THE POLYP. THE ORISE TISSUE RETRACTOR WAS THEN INTRODUCED. WHEN THE DEVICE WAS EXPANDED INSIDE THE PATIENT, A MICRO-PERFORATION WAS NOTED ALONG THE CIRCUMFERENTIAL CUT ON THE PROXIMAL RIGHT SIDE. ANTIBIOTICS WERE ADMINISTERED AND THE PROCEDURE WAS COMPLETED WITH A SNARE. THE PERFORATION WAS REPAIRED WITH A STITCHING DEVICE AT THE CONCLUSION OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AT THE CONCLUSION OF THIS PROCEDURE AND THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: Bowel Perforation

  MAUDE report 7455203 ↗