ORCAPOD?

Additional Manufacturer Narrative

BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A0509 CAPTURES THE REPORTABLE EVENT OF SUCTION BUTTON STICKING.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING EGD (ESOPHAGOGASTRODUODENOSCOPY) AND COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE RED SUCTION VALVE REMAINED DEPRESSED AFTER A FEW SECONDS OF USE. THE PROCEDURE WAS COMPLETED USING ANOTHER ORCA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.