—#173971

Product

The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.

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: The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.

Why it was recalled

The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 10/23/2018, the firm sent a "Medical Device Correction" Letter informing them about the cannula mount button issue and informing all personnel who are involved with da Vinci SP Surgery at their site of the following instructions. 1. Release the cannula mount button in a slow and controlled manner. This will prevent the button from snapping back potentially causing button damage. 2. If button damage occurs prior to procedure, discontinue use of the affected SP system. 3. If button damage occurs during a procedure, call dVSTAT for instructions to complete the procedure. ------------ 4. Complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. The firm will: 1. Have a Surgical Representative schedule a site visit to repair your system as soon as possible. 2. Surgical representatives will be available by phone to answer any questions related to this Medical Device Correction. If you need further information or support concerning this Field Safety Notice, customer can contact their Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com

Recalling firm

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

Distribution

Distribution pattern: Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.

Timeline

Recall initiated: 2018-10-23
Terminated: 2022-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.