inforMED
MalfunctionODC

ORCA

Received Jun 29, 2026 · Event occurred Jun 4, 2026

Report 3005099803-2026-02605 · MDR key 25652763

Device

Generic name

Endoscope Channel Accessory

Model number

SUV-628-50

Catalog number

SUV-628-50

Lot number

0038332100

Product problems

  • Suction Problem
  • Infusion or Flow Problem
  • 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 THE SUCTION BUTTON PHYSICAL RESISTANCE / STICKING.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA DEVICES WERE USED DURING AN UNSPECIFIED NUMBER OF ESOPHAGOGASTRODUODENOSCOPY (EGD), COLONOSCOPY AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURES, IT WAS REPORTED THE SUCTION AND A/W BUTTONS WERE STICKING. SUCTION AND INSUFFLATION ISSUES WERE ALSO REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.