ORCA
Received May 29, 2026 · Event occurred Apr 1, 2026
Report 3005099803-2026-02203 · MDR key 25333514
Device
Generic name
Endoscope Channel Accessory
Manufacturer
Boston Scientific CorporationModel number
SUV-629-50Catalog number
SUV-629-50
Lot number
0037729496
Product problems
- Fluid/Blood Leak
- Infusion or Flow Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER BUTTON WAS LEAKING WATER AND NOT PROVIDING ENOUGH INSUFFLATION. THE PROCEDURE WAS COMPLETED USING 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 A050401CAPTURES THE REPORTABLE EVENT OF AIR WATER BUTTON LEAKING. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.