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. REPORT SOURCE: LITERATURE. THE CITATION OF THE JOURNAL ARTICLE IS BELOW. V. JAIN AND E. SELLERS. A LIFTING AGENT GRANULOMA IDENTIFIED IN WOMAN TWENTY-FIVE WEEKS FOLLOWING SESSILE SERRATED ADENOMA POLYPECTOMY [MEETING ABSTRACT]. AMERICAN COLLEGE OF PHYSICIANS NATIONAL ABSTRACTS COMPETITIONS. 2021; 371-372. (B)(4).

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE CECUM DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. PRIOR TO THE POLYPECTOMY, THE PATIENT UNDERWENT AN INITIAL SCREENING COLONOSCOPY, WHICH REVEALED A 15MM SESSILE SERRATED ADENOMA IN THE CECUM. AFTER AN INJECTION LIFT WITH ORISE GEL, THE POLYP WAS RESECTED UTILIZING HOT SNARE POLYPECTOMY. THREE HEMOSTATIC CLIPS WERE PLACED TO PREVENT FUTURE BLEEDING AND THE PATIENT WAS ADVISED TO HAVE A 6-MONTH FOLLOW-UP COLONOSCOPY. AT THE FOLLOW-UP COLONOSCOPY, A "WELL-HEALED" POLYPECTOMY SCAR WAS NOTED IN THE CECUM. LATERAL TO THE SCAR WAS AN 8MM AREA OF TAN, ABNORMALLY RAISED COLONIC TISSUE. DUE TO THE CONCERN FOR RESIDUAL POLYP, THE PATIENT UNDERWENT A REPEAT HOT SNARE POLYPECTOMY PROCEDURE TO RESECT THE AREA (25 WEEKS FROM INITIAL SUBMUCOSAL INJECTION). THE RESECTED TISSUE WAS CONSISTENT WITH A FOREIGN-BODY REACTION AND AMORPHOUS EOSINOPHILIC MATERIAL CONSISTENT WITH ORISE GEL WAS NOTED. THE PATIENT WAS ADVISED FOR A 3-YEAR SURVEILLANCE INTERVAL FOR HER NEXT COLOSCOPY.