—#178120

Product

da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.

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: System Serial # PSC Serial # VSC Serial # SL0350 665033 Not Affected SL0360 292201 Not Affected SL0361 Not Affected 1000216 SL0362 381021 678362 SL0365 34608 Not Affected SL0366 Not Affected 1000217 SL0369 Not Affected 679520 SL0370 Not Affected 678840 SL0371 Not Affected 305493 SL0372 415418 678699 SL0373 429524 334972 SL0375 332395 678509 SL0376 Not Affected 680721 SL0377 Not Affected 991369 SL0378 266528 872469 SL0379 311710 676421 SL0380 Not Affected 268852 SL0385 Not Affected 304487 SL0386 62043 681143 SL0387 308179 687814 SL0388 Not Affected 688819 SL0389 71796 308181 SL0391 518359 285588 SL0392 Not Affected 685499 SL0393 295941 687813 SL0394 281121 687293 SL0395 43875 689242 SL0396 Not Affected 685077 SL0397 892731 685500 SL0398 Not Affected 330718 SL0399 Not Affected 685080 SL0400 492489 769792 SL0401 292512 682912 SL0402 Not Affected 682536 SL0403 Not Affected 688818 SL0404 278656 691238 SL0406 680584 324350 SL0407 Not Affected 688038 SL0408 81482 331850 SL0409 Not Affected 691236 SL0410 768663 Not Affected SL0411 685403 695335 SL0412 Not Affected 692045 SL0413 Not Affected 698304 SL0415 870352 699139 SL0416 Not Affected 343215 SL0417 697081 692043 SL0418 268716 694230 SL0419 264189 697313 SL0420 279659 699148 SL0423 291981 260861 SL0424 Not Affected 683692

Why it was recalled

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

Root cause (FDA determination)

Component design/selection

Action the firm took

On July 26, 2019, Intuitive sent out a "Urgent Medical Device Correction" letter to affected consignees via FedEx, the Intuitive Customer Portal, and via Email. In addition, to informing their consignees about the recall, the letter also asked consignees to take the following actions: 1. If necessary, please follow the System Troubleshooting section in your specific system user manual for guidance on how to proceed in the scenario where vision loss or a non-recoverable error is experienced, including contacting Intuitive Technical Support. In addition: 2. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures. 3. Inform affected personnel when corrective action has been completed. 4. 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/ 5. In the event the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form. 6. Please retain a copy of this letter and the Acknowledgement Form for your files. 7. An Intuitive representative will contact customers with affected da Vinci Xi, X, and SP Surgical Systems to schedule a site visit and replace the necessary component. 8. If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive 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 " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) " Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 P

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wisconsin and countries of Belgium, Brazil, France, Germany, India, Ireland, Italy, Japan, Norway, Panama, Poland, South Korea, Spain, Taiwan, and United Kingdom

Timeline

Recall initiated: 2019-07-26
Terminated: 2022-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178120. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.