ORISE GEL
Received Mar 16, 2023 · Event occurred Feb 22, 2022
Report 3005099803-2023-01280 · MDR key 16557917
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 ORISE GEL WAS USED AS A LIFTING AGENT DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. DURING THE INITIAL PROCEDURE, APPROXIMATELY 5-7 ML OF ORISE GEL WAS INJECTED TO RESECT A POLYP. INITIAL PATHOLOGY SHOWED TUBULAR ADENOMA. A ROUTINE FOLLOW-UP PROCEDURE WAS PERFORMED 3-4 MONTHS LATER, WHICH REVEALED A FIRM 1 CM SUBMUCOSAL SUBEPITHELIAL LESION. BITE-ON-BITE BIOPSIES WERE OBTAINED DUE TO THE APPEARANCE OF THE FIRM LESION; HOWEVER, PATHOLOGY DID NOT SHOW ANYTHING ABNORMAL. REPORTEDLY, THE PICTURE OF THE LESION APPEARED TO BE SIMILAR TO THE SUB-MUCOSAL DISTORTION THAT HAS BEEN NOTED IN THE PAST. NO FURTHER INTERVENTION WAS NECESSARY, AND THE PATIENT IS DOING WELL.
Remedial action
- Recall