Intuitive—da Vinci Xi EndoWrist Suction Irrigators: Silicone Particle May Be Generated within Irrigator and Introduced into the Patient with Irrigation; Manufacturer Instructs Customers to Stop Use in Intracardiac Procedures

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In a June 7, 2018, Field Safety Notice Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Intuitive states that a silicone particle may be generated within the above irrigators and may be introduced into the patient with irrigation. Intuitive also states that the patient risk for potential silicone particles is specific to intracardiac procedures only; there is a potential for foreign body embolism if a particle is not detected and unintentionally left inside the heart. Intuitive further states that for non-intracardiac procedures, including thoracic or abdominal/pelvic procedures, the above irrigators pose minimal risk to patients. Intuitive states that the potential particle is likely no larger than approximately 3.5 mm in length, of a benign geometry with no sharp edges, and composed of silicone, a bio-inert material with a longstanding implantable history. Intuitive also states that it has received...