—#212603

Product

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K232610
Affected lot / code info: UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.

Why it was recalled

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Root cause (FDA determination)

Device Design

Action the firm took

On February 26, 2025, Intuitive Surgical issued a Urgent: Medical Device Correction to affected consignees via E-Mail. Intuitive asked consignees to take the following actions: 1. Read and understand this notification. 2. Share this notification with all personnel at your site who perform and support da Vinci procedures. 3. Inform affected personnel when the correction has been completed. 4. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. 6. Please inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject devices via the standard complaint process 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 8. Complete and submit the report Online Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. An Intuitive representative will schedule a visit to replace the affected foot tray assembly.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the country of South Korea.

Timeline

Recall initiated: 2025-02-26
Posted by FDA: 2025-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212603. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.