ORISE™ Gel M00519220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729993834), received between Apr 29, 2022 and Oct 21, 2022 — classified as 2 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 10, 2022Open, Classified

   ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

   Z-0224-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED IN (B)(6) 2021. IN (B)(6) 2022, A POSITRON EMISSION TOMOGRAPHY (PET) SCAN WAS PERFORMED TO EVALUATE A LUNG NODULE FOR A SEPARATE ISSUE. THE PET SCAN SHOWED A "HOT SPOT" IN THE DUODENUM AT THE SAME LOCATION AS THE ESD PERFORMED IN (B)(6) 2021. IT WAS STATED THAT THE PHYSICIAN ATTRIBUTED THIS FINDING TO ORISE INFLAMMATION. AS A RESULT OF THE FINDINGS ON THE PET SCAN, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITH BIOPSY IN (B)(6) 2022. THE BIOPSY SHOWED "PEPTIC DUODENITIS WITH ULCERATION".

  Patient problems: Inflammation

  MAUDE report 15655131 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE AND ORISE GEL WAS USED IN THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2022. NEAR THE END OF THE PROCEDURE, THE PATIENT CODED. CODE BLUE PROTOCOL WAS IMPLEMENTED AND THE PATIENT WAS RESUSCITATED. THE PATIENT WAS BROUGHT TO SURGERY TO REPAIR A SMALL PERFORATION IN THE ASCENDING COLON, WHICH WAS SUCCESSFULLY TREATED WITH A CLIP. THE PATIENT DECOMPENSATED OVER THE NEXT FEW DAYS AND DIED ON (B)(6) 2022. THE PATIENT HAD MULTIPLE COMORBIDITIES AND THE FAMILY DECIDED NOT TO CONTINUE LIFE SUPPORT. NO AUTOPSY WAS PERFORMED, HOWEVER THE CLINICAL CAUSE OF DEATH WAS REPORTED TO BE BRAIN DAMAGE. THE PHYSICIAN DEEMED THE PATIENT'S DEATH TO BE NOT RELATED TO THE ORISE DEVICES AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 14256037 ↗