ORISE GEL

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE COLON DURING A COLONOSCOPY PROCEDURE. ON (B)(6), 2022, THE PATIENT UNDERWENT AN INITIAL SCREENING COLONOSCOPY FOR A METASTATIC NEUROENDOCRINE TUMOR OF UNKNOWN PRIMARY. AN IRREGULAR APPEARING AREA WAS OBSERVED AND THE PHYSICIAN WAS NOT CLEAR OF THE ETIOLOGY. THE DECISION WAS MADE TO REMOVE IT VIA ENDOSCOPIC MUCOSAL RESECTION (EMR) AFTER SUBMUCOSAL LIFTING WITH ORISE GEL. THE PHYSICIAN INJECTED 8 ML OF ORISE GEL WITH IRREGULAR LIFT AND AN ODD APPEARANCE TO THE AREA WAS OBSERVED. WITH CONCERN THAT SOME AIR MAY HAVE BEEN INJECTED CAUSING THE AREA TO LOOK "FUNNY", THE PHYSICIAN PROCEEDED WITH A BIOPSY INSTEAD OF THE EMR AT THIS TIME. PATHOLOGY RESULTS SHOWED ADENOMA AFTER THE FIRST COLONOSCOPY. THE PATIENT RETURNED FOR A FOLLOW-UP COLONOSCOPY PROCEDURE ON (B)(6), 2022, FOR POSSIBLE EMR OF THE ADENOMATOUS REGION. DURING THE PROCEDURE, THE SITE WAS EASILY IDENTIFIED AND A SUBMUCOSAL MASS-LIKE LESION NEARLY 2 CM IN SIZE WAS OBSERVED. AN ATTEMPT WAS MADE TO LIFT THE LESION; HOWEVER, THE MASS WAS HARD, AND THE LIFT WAS UNSUCCESSFUL. A SNARE AND FORCEPS WOULD ALSO NOT BITE INTO THE TISSUE. PATHOLOGY RESULTS AGAIN SHOWED ADENOMA. THE PATIENT WAS REFERRED FOR A RIGHT HEMICOLECTOMY PROCEDURE AS THE PATIENT WAS ALREADY PLANNING TO UNDERGO A LIVER RESECTION DUE TO A METASTATIC NEUROENDOCRINE LESION. THE SURGICAL SPECIMEN FROM THE RIGHT HEMICOLECTOMY SHOWED GRANULOMA AND ADENOMA.