ORISE GEL

Additional Manufacturer Narrative

THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. OTHER PHYSICIAN INFORMATION: DR. (B)(6). REPORT SOURCE: LITERATURE. EDITORIAL TITLE; EDGE OF UNCERTAINTY: WILL NOT GET FOOLED AGAIN. (B)(4).

Description of Event or Problem

AN EDITORIAL LITERATURE PUBLICATION WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 21, 2021 INVOLVING THE POTENTIAL DISTORTION ARTIFACT OF ORISE GEL LIFTING AGENT. ALTHOUGH DIFFERENT INJECTION SOLUTIONS CAN ENHANCE ENDOSCOPIC MUCOSAL RESECTION (EMR) PERFORMANCE, THEY ARE NOT ENTIRELY SAFE BECAUSE SOME CAN CAUSE HISTOPATHOLOGIC ARTIFACTS. THE LITERATURE POINTS TO ORISE GEL, ALLEGING THAT SUBMUCOSAL DISTORTION WITH BLUE-GRAY MATERIAL RESEMBLING MUCIN HAS BEEN DESCRIBED ON IMMEDIATE HEMATOXYLIN AND EOSIN-STAINED HISTOPATHOLOGIC SPECIMENS. THEY STATE THAT THIS CAN POTENTIALLY LEAD TO ADENOCARCINOMA MISDIAGNOSIS. THE HISTOLOGIC ARTIFACT APPEARS TO EVOLVE OVER TIME, CHANGING TO AN AMORPHOUS EOSINOPHILIC MATERIAL WITH ASSOCIATED MULTINUCLEATED GIANT CELL REACTION, COMMONLY SEEN IN BIOPSY AND RESECTION SPECIMENS. ORISE GEL HAS FOOLED PHYSICIANS IN THIS RESPECT, TO THE POINT OF PERFORMING ADDITIONAL ENDOSCOPIC AND BIOPSY PROCEDURES GIVEN THE CONCERN FOR SUBMUCOSAL TUMOR GROWTH CAUSED BY THE DISTORTION ARTIFACT OF ORISE GEL.