Orca

Additional Manufacturer Narrative

BLOCK B3 (DATE OF EVENT): DATE OF EVENT WAS APPROXIMATED TO 06/01/2026 AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF THE AIR/WATER VALVE FLUID/BLOOD LEAK.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCAPOD 3 WAS USED IN THE COLON, ESOPHAGUS AND STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY PROCEDURES FOR SCREENING AND BIOPSY PERFORMED ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, WHEN PRIMING OF THE LENS-CLEANING CHANNEL, THE BLUE AIR/WATER BUTTON BECAME STUCK IN THE DEPRESSED POSITION AND FAILED TO RETURN TO ITS NORMAL STATE. ADDITIONALLY, WATER WAS SLOWLY LEAKING OUT OF THE SEAL DURING THE CASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.