—#180598

Product

da Vinci Xi Surgical System

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K131861
Affected lot / code info: Model: IS4000 UDI: 00886874114216 Device Listing: D215864 For System Name and USM Serial Numbers, refer to: ISIFA2018-15-C 806.10 Report_Affected Products List - Copy" files in Associated Documents.

Why it was recalled

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Root cause (FDA determination)

Process control

Action the firm took

On 11/21/2018, the firm sent an "Urgent Medical Device Correction" Notification to its customers informing them that the firm had become aware of specific surgical systems were shipped with a manufacturing variation in the arm, which may result in a persistent recoverable fault (error 23087) with could occur prior or during a surgical procedure. The firm emphasized that as indicated in the User Manual, if this fault is persistent, ten the affected arm may be disabled. The firm is instructing that: 1. Inform surgeons and patient side assistants using the surgical system to read and understand the contents of this letter. 2. Additionally, forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who perform procedures. 3. Place a copy of this letter with their User Manual until the corrective action has been completed. 4. Inform affected personnel when corrective action has been completed. 5. Please log into the Recalling Firm's Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 6. In the case where the online resource cannot be used, complete the attached Acknowledgement Form and return it via fax. 7. Please retain a copy of the letter and the acknowledgement form for their files. Actions being taken by the Recalling Firm are: 1. To correct the issue described in this Field Safety Notice, an Recalling Firm representative will schedule a site visit to replace the affected arm. 2. A copy of the Field Safety Notice will be provided to customers with affected surgical systems. 3. A Recalling Firm's representatives will be available by phone to answer any questions related to this Field Safety Notice. Contact Information for any questions: If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Repres

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.

Timeline

Recall initiated: 2018-11-21
Terminated: 2022-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180598. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.