ORISE GEL
Received Nov 23, 2022 · Event occurred Oct 1, 2022
Report 3005099803-2022-06913 · MDR key 15850568
Device
Generic name
Submucosal Injection Agent
Manufacturer
Boston Scientific CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
81 YR · Female
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
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. REPORT SOURCE: LITERATURE. THE CITATION OF THE JOURNAL ARTICLE IS BELOW. JONES AT, BROOME JM, ZELHART MD. COMBINED ENDOSCOPIC ROBOTIC SURGERY FOR COMPLEX COLONIC POLYP RESECTION: CASE SERIES. SURG ENDOSC 2021. PMID: 34494158 DOI: 10.1007/S00464-021-08702-9.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE CECUM DURING A COMBINED ENDOSCOPIC ROBOTIC SURGERY (CERS) ON AN UNKNOWN DATE. PER LITERATURE, AN 81-YEAR-OLD FEMALE UNDERWENT A SUCCESSFUL RESECTION OF A 13 CM POLYP. HOWEVER, THE PATIENT EXPERIENCED A POST-OPERATIVE BLEED (WITHIN 30 DAYS POST PROCEDURE) AT THE RESECTION SITE. IT WAS REPORTED THE PATIENT REMAINED IN THE HOSPITAL BEYOND THE STANDARD OF CARE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.