ORISE GEL
Received Sep 12, 2022 · Event occurred Jul 16, 2021
Report 3005099803-2022-04988 · MDR key 15407094
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationProduct problems
- Defective Device
- Adverse Event Without Identified Device or Use Problem
- Defective Device
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Granuloma
- Obstruction/Occlusion
- Granuloma
- Obstruction/Occlusion
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6), 2021. THE PATIENT HAD A POLYP REMOVED USING ORISE GEL AS THE LIFTING AGENT. DURING A FOLLOW-UP SURVEILLANCE COLONOSCOPY, THEY FOUND THE PATIENT HAD DEVELOPED A STRICTURE AT THE SITE OF THE RESECTION. DUE TO THE STRICTURE, A PARTIAL COLECTOMY WAS PERFORMED. SURGICAL PATHOLOGY DEMONSTRATED THAT THERE WAS A GIANT CELL REACTION TO THE ORISE GEL AT THE SITE, AND THEY BELIEVE IT WAS THIS GRANULOMATOUS REACTION THAT LIKELY CAUSED THE STRICTURE. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATION AND WAS ADMITTED POST-OPERATIVELY FOR MONITORING.
Additional Manufacturer Narrative
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 DURING A COLONOSCOPY PERFORMED ON (B)(6) 2021. THE PATIENT HAD A POLYP REMOVED USING ORISE GEL AS THE LIFTING AGENT. DURING A FOLLOW-UP SURVEILLANCE COLONOSCOPY, THEY FOUND THE PATIENT HAD DEVELOPED A STRICTURE AT THE SITE OF THE RESECTION. DUE TO THE STRICTURE, A PARTIAL COLECTOMY WAS PERFORMED. SURGICAL PATHOLOGY DEMONSTRATED THAT THERE WAS A GIANT CELL REACTION TO THE ORISE GEL AT THE SITE, AND THEY BELIEVE IT WAS THIS GRANULOMATOUS REACTION THAT LIKELY CAUSED THE STRICTURE. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATION AND WAS ADMITTED POST-OPERATIVELY FOR MONITORING.
Additional Manufacturer Narrative
BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H2: CORRECTION: BLOCK H6 DEVICE CODE HAS BEEN UPDATED. BLOCK H6: IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION.