ORCA
Received Feb 19, 2026 · Event occurred Jan 19, 2026
Report 3005099803-2026-00655 · MDR key 24391906
Device
Generic name
Endoscope Channel Accessory
Manufacturer
Boston Scientific CorporationModel number
SUV-629-50Catalog number
2219-02
Lot number
0037136839
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 ORCAPOD 4 WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WATER WAS OBSERVED LEAKING FROM THE AIR/WATER VALVE ON THE SCOPE PORT AND THE FLOW WAS CONSTANT. 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.