ORCAPOD?

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED FOR COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (b)(6) 2026, FOR SCREENING. DURING THE PROCEDURE, THE BUTTON OPERATED AS INTENDED FOR APPROXIMATELY THE FIRST FIVE MINUTES. DURING WITHDRAWAL, INSUFFLATION BECAME INADEQUATE, MAKING COMPLETE VISUALIZATION OF THE COLONIC WALLS DIFFICULT. THE CUSTOMER REPORTED THAT AIR FLOW CEASED COMPLETELY AND THEN BECAME INTERMITTENT. WATER WAS LEAKING FROM THE THROUGH HOLE OF THE A/W VALVE. AS A RESULT OF THESE ISSUES, THE PROCEDURE WAS DELAYED BY APPROXIMATELY TEN TO FIFTEEN MINUTES.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK D2B: SUBSEQUENT PRODUCT CODE FEQ, OCX.BLOCK H6:IMDRF DEVICE CODE A050401CAPTURES THE REPORTABLE EVENT OF AIR WATER BUTTON LEAKING.