ORISE GEL
Received Feb 18, 2022 · Event occurred Jan 14, 2022
Report 3005099803-2022-00865 · MDR key 13563905
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationModel number
M00519201Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Scar Tissue
- Fibrosis
- Scar Tissue
- Fibrosis
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT WAS INJECTED WITH ORISE GEL IN THE RECTUM DURING A PROCEDURE ON AN UNKNOWN DATE. POST-PROCEDURE, SIGNIFICANT TISSUE SCARRING AND FIBROSIS OCCURRED. THE PHYSICIAN BELIEVES THE ORISE IS SCARRING THE TISSUE POST-PROCEDURE. ON (B)(6) 2022, THE PATIENT WENT TO SURGERY FOR THEIR DISEASE. DURING THAT ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE FOR RESECTION OF CANCEROUS LESION, IT WAS NOTED THAT THE ORISE GEL HAD HARDENED SO MUCH TISSUE THAT THEY HAD TO "UPGRADE" THE SURGERY TO EXCISE MORE TISSUE THAN ORIGINALLY NEEDED. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. FOLLOWING THE PROCEDURE, THE PATIENT OUTCOME WAS REPORTED TO BE "FULLY RECOVERED".
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS IMPLANTED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.