ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Class I - Dangerous

🏥 Medical Devices Recalled: September 11, 2014 Intuitive Surgical Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
PATIENT SIDE CART, PS4000. Part Number: 380652 Serial Numbers: 353668 351929 354943 351749 354389 351849 355824 363594 361993 360419 358104 357083 351852 351845 361323 358107 364412 364505 361994 364001 349166 364112 358774 359361 357082 363784 353632 364343 358109 358848 351052 354234 354552 356258 363752 354233 358775 364200 359222 364619 363868 354714 361989 361391 361094 351853 353410 355206 357698 358480 365395 359223 355996 363681 360417 355623 365465 365839 356530 364620 365928 365862 356532 366904 366884 367674 368046 367426 356683 360413 356533 368071 368681 358930 357081.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Intuitive Surgical, Inc.
Reason for Recall:: Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Product Codes/Lot Numbers:

PATIENT SIDE CART, PS4000. Part Number: 380652 Serial Numbers: 353668 351929 354943 351749 354389 351849 355824 363594 361993 360419 358104 357083 351852 351845 361323 358107 364412 364505 361994 364001 349166 364112 358774 359361 357082 363784 353632 364343 358109 358848 351052 354234 354552 356258 363752 354233 358775 364200 359222 364619 363868 354714 361989 361391 361094 351853 353410 355206 357698 358480 365395 359223 355996 363681 360417 355623 365465 365839 356530 364620 365928 365862 356532 366904 366884 367674 368046 367426 356683 360413 356533 368071 368681 358930 357081.