ORISE GEL
Received Oct 21, 2022 · Event occurred Sep 1, 2022
Report 3005099803-2022-06096 · MDR key 15651339
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
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS INJECTED TO RESECT A GASTRIC POLYP ON AN UNKNOWN DATE. ON SURVEILLANCE ENDOSCOPY, RECURRENCE OF THE POLYP WAS NOTED. THE POLYP WAS RESECTED AGAIN, AND THE ENTIRE SPECIMEN WAS FOUND TO BE ORISE GEL. IT WAS DETERMINED THAT THE ORISE GEL RESULTED IN A FOREIGN BODY RESPONSE MIMICKING A POLYP, AND THE PATIENT UNDERWENT UNNECESSARY ADDITIONAL INTERVENTION.
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.
Additional Manufacturer Narrative
BLOCK B3: 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. 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 H11: BLOCK H6 CONCLUSION CODE WAS CORRECTED BASED ON THE INVESTIGATION FINDINGS.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS INJECTED TO RESECT A GASTRIC POLYP ON AN UNKNOWN DATE. ON SURVEILLANCE ENDOSCOPY, RECURRENCE OF THE POLYP WAS NOTED. THE POLYP WAS RESECTED AGAIN, AND THE ENTIRE SPECIMEN WAS FOUND TO BE ORISE GEL. IT WAS DETERMINED THAT THE ORISE GEL RESULTED IN A FOREIGN BODY RESPONSE MIMICKING A POLYP, AND THE PATIENT UNDERWENT UNNECESSARY ADDITIONAL INTERVENTION.
Remedial action
- Notification