—#179353

Product

da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) 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 IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are four USM per da Vinci X surgical system.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171294
Affected lot / code info: UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369

Why it was recalled

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Root cause (FDA determination)

Process control

Action the firm took

On 04/11/2019, the firm sent an "Urgent Medical Device Correction" notifications via FedEx to its customers informing them that the Recalling Firm has become aware that specific Surgical Systems arms have the potential to encounter friction in specific instrument arm orientations. As a result, sluggish, jerky, or hesitating motion may be experienced at the instrument tip and/or resistance felt in the hand controls. To correct this issue, a Recalling Firm's representative will schedule a site visit to perform evaluations on their systems. Based on the results of the evaluation, any necessary corrections will be prioritized appropriately. In addition: Customers are informed and instructed that If any of instruments arms exhibit sluggish, jerky, or hesitating motion, or if you feel significant resistance from the hand controls with no interference between arms/instruments, contact the da Vinci Surgical Technical Assistance Team (dVSTAT) as soon as possible. General Acknowledgement 1. Forward this letter to your Risk Manager, OR Director, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures. 2. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 3. In the event the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. representatives will be available by phone to answer any questions related to this Medical Device Correction. An Intuitive representative will schedule a site visit with your hospital to perform the inspection and provide any potential correction activity for the instrument arms of your system(s). If you need further information or support concerning this Medical Devic

Recalling firm

Firm: Intuitive Surgical Inc
Address: 950 Kifer Rd, Sunnyvale, California 94086-5206

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom.

Timeline

Recall initiated: 2019-04-11
Terminated: 2024-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179353. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.