Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

On 4/22/2026, correction notices were mailed and emailed to customers who were asked to do the following: 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep a copy of the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. A firm Representative will schedule a site visit to perform an inspection of the system. If you need further information or support concerning this Medical Device Correction, please contact your da Vinci SP Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected]. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or [email protected] " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or [email protected] " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or [email protected] " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)