ORISE GEL
Received Dec 13, 2022 · Event occurred Nov 1, 2022
Report 3005099803-2022-07527 · MDR key 15974762
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
- Granuloma
- Granuloma
Narrative
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.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE ON AN UNKNOWN DATE. DURING ROUTINE SURVEILLANCE 3 MONTHS POST EMR, A FOREIGN BODY REACTION WAS OBSERVED AT THE RESECTION SITE. REPORTEDLY, THE AREA LOOKED "LIFTED". A BIOPSY WAS PERFORMED ON THE AREA TO ELIMINATE/ RULE OUT MALIGNANCY, WHICH CAME BACK NEGATIVE AND BENIGN. THE PATIENT RETURNED 3 MONTHS LATER (6 MONTHS POST INITIAL EMR) AND THE AREA LOOKED COMPLETELY NORMAL AND FLAT.
Remedial action
- Notification