ORISE GEL
Received Sep 23, 2022 · Event occurred Aug 26, 2022
Report 3005099803-2022-05298 · MDR key 15474634
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationProduct problems
- Component Missing
- Device Contamination with Chemical or Other Material
- Material Integrity Problem
- Component Missing
- Device Contamination with Chemical or Other Material
- Material Integrity Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT BLACK LIQUID WAS PRESENT IN THE ORISE GEL SYRINGE. ADDITIONALLY, THE LUER LOCK ADAPTOR AND TIP CAP WAS MISSING FROM THE SYRINGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ORISE GEL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
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).