—#180439

Product

da Vinci SP surgical system

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K173906
Affected lot / code info: Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030

Why it was recalled

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

Root cause (FDA determination)

Software design

Action the firm took

The firm sent a letter to consignees on April 1, 2020 stating that an Intuitive representative will schedule a site visit to provide a software update as soon as possible. Firm representatives will be available by phone to answer any questions related to this Medical Device Correction. Actions taken by the customer are to: Inform all personnel who are involved with the affected device at your site of the following instructions: 1.If vibrations are sensed at the instrument and/or endoscope tips in Adjust Mode and the instrument arm is near its vertical limit: a.Cease applying sustained force against the hand control haptic feedback, b.Exit Adjust Mode by releasing the Endoscope Control pedal c.Exit following mode by removing your head from the Surgeon Console, or d.Press the Emergency Stop button. Any of these actions will stop the vibration. 2.If mechanical vibration persists, discontinue use of the system and contact Technical Support. 3.Inform affected personnel when the software update has been completed by the Intuitive representative. 4.Complete the attached Acknowledgment Form and return it via fax or email to Intuitive as instructed on the form. 5.Please retain a copy of this letter and the acknowledgment form for your files. Customers with additional questions: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST); South Korea: + 82-02-3271-3200, Opt. 3 (9 AM to 6 PM KSTJ)

Recalling firm

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

Distribution

Distribution pattern: U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea

Timeline

Recall initiated: 2019-04-01
Posted by FDA: 2020-06-03
Terminated: 2021-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.