MalfunctionODC
ORCA?
Received Apr 9, 2026 · Event occurred Mar 13, 2026
Report 3005099803-2026-01302 · MDR key 24834530
Device
Generic name
Endoscope Channel Accessory
Manufacturer
Boston Scientific CorporationModel number
SUV-617-50Catalog number
SUV-617-50
Lot number
0038048039
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WATER SPRAYED OUT OF THE CENTER OF THE A/W VALVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A050401 CAPTURES THE REPORTABLE EVENT OF A/W VALVE FLUID LEAK.