ORCA
Received Jul 14, 2026 · Event occurred Jun 17, 2026
Report 3005099803-2026-02806 · MDR key 25814040
Device
Generic name
Endoscope Channel Accessory
Manufacturer
Boston Scientific CorporationModel number
SUV-629-50Catalog number
SUV-629-50
Lot number
0038973974
Product problems
- Fluid/Blood Leak
- Suction Problem
- Human-Device Interface Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A050401CAPTURES THE REPORTABLE EVENT OF AIR WATER BUTTON LEAKING.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE AIR/WATER VALVE LEAKED, THE SUCTION VALVE EXPERIENCED UNSPECIFIED ISSUES, AND THE BUTTONS WERE DIFFICULT TO PRESS. THESE ISSUES REPORTEDLY PROLONGED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.