ORISE GEL
Received Dec 27, 2024 · Event occurred Dec 1, 2024
Report 3005099803-2024-06608 · MDR key 21028641
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
NA · Unknown
- Granuloma
- Granuloma
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN ORISE GEL THROUGH THE ARTICLE, GONE BUT NOT FORGOTTEN: EXPANDING THE SPECTRUM OF ORISE (SUBMUCOSAL LIFTING AGENT) ASSOCIATED DIAGNOSTIC PITFALLS AND COMPLICATIONS, BY POOJA DHORAJIYA, ET AL. PER THE ARTICLE, ALL SPECIMENS SHOWING LIFTING AGENT GRANULOMATA (LAGS) ASSOCIATED WITH THE USE OF ORISE WERE IDENTIFIED. 34 CASES (28 RESECTIONS AND 6 REPEAT ENDOSCOPIC MUCOSAL RESECTION SPECIMENS) SHOWED LAG. IN 64.2% OF CASES, A MASS LESION WAS SEEN GROSSLY BUT NO MALIGNANCY WAS IDENTIFIED MICROSCOPICALLY. LAGS WERE SEEN UP TO 10 MONTHS AFTER THE USE OF ORISE IN THE PRIOR ENDOSCOPIC PROCEDURE.
Additional Manufacturer Narrative
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE. BLOCK G2: DHORAJIYA P, ET AL. J CLIN PATHOL 2024;0:1-5. 10.1136/JCP-2024-209419.