ORISE GEL
Received Mar 22, 2023 · Event occurred Feb 1, 2023
Report 3005099803-2023-01351 · MDR key 16589504
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Local Reaction
- Local Reaction
Narrative
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. IMPACT CODE F2201 CAPTURES THE REPORTABLE EVENT OF BIOPSY.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT 15-20ML OF ORISE GEL WAS USED AS A LIFTING AGENT IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE ON AN UNKNOWN DATE. THE PATIENT UNDERWENT AN INITIAL EMR ON A LARGE COLONIC POLYP MEASURING NEARLY 3-4CM. A ROUTINE REPEAT SURVEILLANCE COLONOSCOPY WAS DONE THREE MONTHS LATER, WHICH NOTED A FIRM SUBEPITHELIAL LESION IN THE SAME AREA MEASURING AROUND 1.5CM. BITE-ON-BITE BIOPSIES WERE PERFORMED ON THE FIRM LESION, BUT THE PATHOLOGY RESULTS CAME BACK AS NORMAL TISSUE. REPORTEDLY, THE PATIENT WILL RETURN FOR ADDITIONAL SURVEILLANCE IN 9-12 MONTHS TO REEVALUATE THE LESION.
Remedial action
- Recall