inforMED — FDA medical device performance lookup

Device

Generic name

Submucosal Injection Agent

Manufacturer

Boston Scientific Corporation

Model number

UNK-P-ORISE_GEL

Product problems

Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem

Patient

Not reported

Muscle Spasm(s)
No Consequences Or Impact To Patient
Muscle Spasm(s)
No Consequences Or Impact To Patient

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. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE ASCENDING COLON, DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS OBSERVED THAT WHEN THE ORISE GEL WAS INJECTED, IT CAUSED COLONIC SPASMS IN THE RIGHT COLON. THE SPASMS WERE TREATED USING GLUCAGON AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL ORISE GEL. NO PATIENT COMPLICATIONS WERE NOTED, AS A RESULT OF THE COLONIC SPASMS.

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 H10: ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE ASCENDING COLON, DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS OBSERVED THAT WHEN THE ORISE GEL WAS INJECTED, IT CAUSED COLONIC SPASMS IN THE RIGHT COLON. THE SPASMS WERE TREATED USING GLUCAGON AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL ORISE GEL. NO PATIENT COMPLICATIONS WERE NOTED, AS A RESULT OF THE COLONIC SPASMS. ACCORDING TO THE PHYSICIAN, THE COLONIC SPASMS MUST HAVE BEEN PATIENT RELATED AND THE ORISE GEL WAS UNRELATED TO THE SPASMS.

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. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE ASCENDING COLON, DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS OBSERVED THAT WHEN THE ORISE GEL WAS INJECTED, IT CAUSED COLONIC SPASMS IN THE RIGHT COLON. THE SPASMS WERE TREATED USING GLUCAGON AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL ORISE GEL. NO PATIENT COMPLICATIONS WERE NOTED, AS A RESULT OF THE COLONIC SPASMS.