MalfunctionODC
ORCA?
Received May 28, 2026 · Event occurred Mar 23, 2026
Report 3005099803-2026-02157 · MDR key 25319714
Device
Generic name
Endoscope Channel Accessory
Manufacturer
Boston Scientific CorporationModel number
SUV-617-50Catalog number
SUV-617-50
Lot number
0036325092
Product problems
- Physical Resistance/Sticking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION BUTTON STICKING. BLOCK E1 PHONE NUMBER: (B)(6).
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA BUTTON WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2026. THE SUCTION BUTTON COULD NO LONGER BE PRESSED. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.