ORCA?

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. THE SUCTION VALVE BECAME STUCK, AND THE BUTTON HAD TO BE REPLACED WITH ORCA BUTTONS FROM ANOTHER LOT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION VALVE STICKING. BLOCK H7: ON (B)(6) 2026, BOSTON SCIENTIFIC INITIATED A FIELD SAFETY CORRECTIVE ACTION (FSCA - BOSTON SCIENTIFIC REFERENCE: (B)(4)) 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 (B)(6) 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. BLOCK H2: DEVICE ANALYSIS. THE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO ANALYSIS COULD BE PERFORMED TO IDENTIFY A POTENTIAL DEVICE DEFECT AND THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. ADDITIONALLY, WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN WHAT FACTOR MOST LIKELY CONTRIBUTED TO THE EVENT. SINCE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENT, CAUSE NOT ESTABLISHED WAS SELECTED AS THE MOST PROBABLE CAUSE OF THE COMPLAINT.