ORISE GEL

Additional Manufacturer Narrative

DATE OF EVENT: 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. IMPACT CODE (B)(4).

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE COLON DURING A COLECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ORISE GEL WAS USED TO LIFT AN 8MM POLYP IN THE COLON. THE POLYP WAS RESECTED USING A HOT SNARE AND SENT TO PATHOLOGY, WHICH SHOWED INVASIVE CARCINOMA. A SECOND GASTROENTEROLOGY PATHOLOGIST REVIEWED THE POLYP AND CONFIRMED INVASIVE CANCER. IN A PHOTO PROVIDED BY THE CUSTOMER, REMNANT ORISE GEL WAS OBSERVED AT THE RESECTION SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN 11 DAYS AFTER THE COLON POLYP REMOVAL. THE CT SCAN SHOWED AREA WALL THICKENING MEASURING 1CM IN THICKNESS AND 3CM IN LENGTH CONCERNING FOR CANCER. THE PATIENT WAS REFERRED TO ANOTHER GASTROENTEROLOGIST FOR A REPEAT ENDOSCOPY PROCEDURE, AND ALSO TO A SURGEON. HOWEVER, THE PATIENT NEVER SAW THE SECOND GASTROENTEROLOGIST AND WAS TAKEN FOR COLONIC RESECTION BY THE SURGEON. THE RESECTED SPECIMEN SHOWED A 1.2CM X 1CM FIRM TAN LESION. PATHOLOGY RESULTS NOTED NO EVIDENCE OF CANCER IN THE SPECIMEN OR GRANULOMA/FOREIGN BODY REACTION.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE COLON DURING A COLECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ORISE GEL WAS USED TO LIFT AN 8MM POLYP IN THE COLON. THE POLYP WAS RESECTED USING A HOT SNARE AND SENT TO PATHOLOGY, WHICH SHOWED INVASIVE CARCINOMA. A SECOND GASTROENTEROLOGY PATHOLOGIST REVIEWED THE POLYP AND CONFIRMED INVASIVE CANCER. IN A PHOTO PROVIDED BY THE CUSTOMER, REMNANT ORISE GEL WAS OBSERVED AT THE RESECTION SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN 11 DAYS AFTER THE COLON POLYP REMOVAL. THE CT SCAN SHOWED AREA WALL THICKENING MEASURING 1CM IN THICKNESS AND 3CM IN LENGTH CONCERNING FOR CANCER. THE PATIENT WAS REFERRED TO ANOTHER GASTROENTEROLOGIST FOR A REPEAT ENDOSCOPY PROCEDURE, AND ALSO TO A SURGEON. HOWEVER, THE PATIENT NEVER SAW THE SECOND GASTROENTEROLOGIST AND WAS TAKEN FOR COLONIC RESECTION BY THE SURGEON. THE RESECTED SPECIMEN SHOWED A 1.2CM X 1CM FIRM TAN LESION. PATHOLOGY RESULTS NOTED NO EVIDENCE OF CANCER IN THE SPECIMEN OR GRANULOMA/FOREIGN BODY REACTION. DR. (B)(6) HAD UNDERGONE SURGERY BASED ON CT FINDINGS. WE DID NOT HAVE THE PATHOLOGY FINDING FROM THE SURGICAL SPECIMEN. DR. WUERTH HAS REACHED OUT TO ME AND CONFIRMED THAT THE SURGICAL SPECIMEN DID SHOW FOREIGN BODY REACTION/ GRANULOMA, AND NO MALIGNANCY WAS IDENTIFIED.

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 H2: BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 14, 2022. BLOCK H6: IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION.