471205

The Intuitive Surgical EndoWrist® 471205 is an 8 mm reusable robotic instrument featuring fenestrated jaws and bipolar cautery capability for use with da Vinci® X and Xi surgical systems. It has a manufacturer-listed service life of 14 uses. The instrument is supplied nonsterile and requires processing and sterilization before use in accordance with the manufacturer’s instructions. Intuitive Selling quantity Each — 1 instrument. The manufacturer-submitted device record lists a device count of 1. “14 uses” describes the catalog-listed instrument life—not a package of 14 instruments. AccessGUDID Important catalog distinction: This is a reusable, nonsterile instrument, not a sterile, single-use disposable. Keep condition and verified remaining uses separate from the standard description; do not advertise “14 uses remaining” based on the REF alone. AccessGUDID Important inventory check: recall history FDA Class II recall Z-0878-2025 covers specified batches of part/revision 471205-17, concerning frayed or broken grip cables. The action was initiated on December 19, 2024. openFDA This is a device correction, not a blanket instruction to discard every instrument bearing this REF. The notice permits continued use according to the manufacturer’s instructions and inspection requirements, but directs users to remove instruments with frayed or broken grip cables from use. Before listing inventory as available for sale, verify its full revision and lot and confirm compliance with the corrective instructions.