ORISE GEL

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 UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL EMDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED DURING A PROCEDURE. THE PATIENT RECEIVED AN INITIAL ENDOSCOPIC PROCEDURE USING ORISE GEL TO ATTEMPT TO LIFT A LESION IN (B)(6) 2021, HOWEVER WAS REFERRED FOR SURGERY IN (B)(6) 2022. IN (B)(6) 2021, THE INITIAL PROCEDURE WAS COMPLETED USING ORISE GEL TO LIFT AND COMPLETE AN EN BLOC RESECTION. IN (B)(6) 2022, THE PATIENT CAME BACK AND ANOTHER PHYSICIAN BIOPSIED AND TATTOOED THE AREA. IN (B)(6) 2022, THE PATIENT WAS SENT BACK TO TAKE MORE BIOPSIES AND A FULL THICKNESS RESECTION, BUT THE LESION WOULD NOT PULL INTO THE SCOPE. PATHOLOGY CAME BACK FROM BOTH PHYSICIANS WITH A SERRATED DIAGNOSIS. THE PHYSICIAN BELIEVES THIS IS STEMMING FROM HIS INABILITY TO GET A FULL EN BLOC RESECTION BACK IN (B)(6) DURING THE INITIAL PROCEDURE. ON (B)(6) 2022, PATHOLOGY CAME BACK WITH ATYPIA. THE PATIENT WAS REFERRED FOR SURGERY AND UNDERWENT A PARTIAL RIGHT HEMICOLECTOMY TO HAVE IT REMOVED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED DURING A PROCEDURE. THE PATIENT RECEIVED AN INITIAL ENDOSCOPIC PROCEDURE USING ORISE GEL TO ATTEMPT TO LIFT A LESION IN (B)(6) 2021, HOWEVER WAS REFERRED FOR SURGERY IN (B)(6) 2022. IN (B)(6) 2021, THE INITIAL PROCEDURE WAS COMPLETED USING ORISE GEL TO LIFT AND COMPLETE AN EN BLOC RESECTION. IN (B)(6) 2022, THE PATIENT CAME BACK AND ANOTHER PHYSICIAN BIOPSIED AND TATTOOED THE AREA. IN (B)(6) 2022, THE PATIENT WAS SENT BACK TO TAKE MORE BIOPSIES AND A FULL THICKNESS RESECTION, BUT THE LESION WOULD NOT PULL INTO THE SCOPE. PATHOLOGY CAME BACK FROM BOTH PHYSICIANS WITH A SERRATED DIAGNOSIS. THE PHYSICIAN BELIEVES THIS IS STEMMING FROM HIS INABILITY TO GET A FULL EN BLOC RESECTION BACK IN JULY DURING THE INITIAL PROCEDURE. ON (B)(6) 2022, THE COLON RESECTION WAS PERFORMED. THE PATIENT WAS REFERRED FOR SURGERY AND UNDERWENT A PARTIAL RIGHT HEMICOLECTOMY TO HAVE IT REMOVED.

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 UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. BLOCK H10: THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL EMDR WILL BE FILED. BLOCK H11: B5 HAS BEEN UPDATED BASED ON THE INFORMATION RECEIVED ON 28JUN2022.