da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen). The 3DHD endoscope assembly (endoscope and camera head) can be used manually (that is, handheld, as with a traditional endoscopy cart) or can be mounted on the camera arm to assist with preoperative exploration. Also integrated in the Vision System Cart is the Illuminator. The illuminator has a single light source attached to the endoscopy assembly by the light guide cable. It provides illumination inside the body for vision of the surgical field. The Illuminator monitors the life left on the lamp module and notifies the customer when replacement is recommended.

Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.

Intuitive Surgical sent an Urgent Medical Device Correction letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to open the illuminator and replace any metal-finish lamp modules with plastic finish lamp modules, if customers do not have a replacement plastic-finish lamp module available, they may continue to use the metal-finish lamp module until they receive a replacement. If the message "illuminator lamp module error: Please reseat or replace lamp module" is displayed on the patient side monitor and the surgeon console, contact intuitive Surgical Customer Service. Customers were also instructed to examine any remaining or spare inventory to identify any metal-finish lamp modules and return them to Intuitive Surgical for credit. Customers were instructed to ensure all affected personnel are fully informed of this Urgent Medical Device Corrrection letter. Customers should complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. Customers with questions should contact Intuitive Surgical Customer Service. For questions regarding this recall call 408-523-2244.