ORCA?

Additional Manufacturer Narrative

BLOCK H6: IMDRF A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION VALVE STICKING BLOCK H2 DEVICE ANALYSIS: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS TO IDENTIFY ANY DEFECT WITH THE DEVICE. WITHOUT A PRODUCT RETURNED, NO PRODUCT ANALYSIS COULD BE CONDUCTED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. NO DEVICE TECHNICAL ANALYSIS WAS PERFORMED DUE TO THE UNAVAILABILITY OF THE RETURNED PRODUCT, THEREFORE NO POTENTIAL FAILURE MODE COULD BE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE, AND WITHOUT PROPER EVALUATION OF THE DEVICE IT REMAINS UNKNOWN WHAT CONTRIBUTED TO THE EVENT, SO THE CAUSE IS CLASSIFIED AS CAUSE NOT ESTABLISHED. BLOCK H7: ON MAY 12, 2026, BOSTON SCIENTIFIC INITIATED A FIELD SAFETY CORRECTIVE ACTION (FSCA - BOSTON SCIENTIFIC REFERENCE: 97585870-FA) THAT INCLUDED THE REMOVAL OF ORCA? SINGLE USE AIR/WATER AND SUCTION VALVES ASSOCIATED WITH BATCH NUMBER 38400303 DUE TO INCREASED REPORTS OF SUCTION BUTTON STICKING ISSUES. A COMMUNICATION WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON MAY 12, 2026, WITH INSTRUCTIONS TO IMMEDIATELY STOP FURTHER USE OR DISTRIBUTION OF ORCA? SINGLE USE AIR/WATER AND SUCTION VALVES ASSOCIATED WITH BATCH NUMBER 38400303, REMOVE THE DEVICES FROM INVENTORY, AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. BOSTON SCIENTIFIC WILL CONTINUE TO CLOSELY MONITOR AND TREND SIMILAR EVENTS AND ASSOCIATED RISKS, AS OUTLINED IN OUR QUALITY SYSTEMS PROCESS.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC THAT ORCA AIR WATER AND SUCTION VALVES WERE USED IN A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. AFTER 5 MINUTES INTO THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION AND RECURRED SEVERAL TIMES; IT WAS THEN REPLACED WITH ANOTHER ORCA BUTTON, WHICH FUNCTIONED PROPERLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.