da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic 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 labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.

Class I - Dangerous

🏥 Medical Devices Recalled: March 3, 2015 Intuitive Surgical Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424, 1311140196, 1311140146, 1311140252, 1311140010, 1311140289, 1311140578, 1311140435, 1311140349, 1311140411, 1311140389, 1311140156, 1311140198, 1311140452, 1311140186, 1311140554 1311140335, 1311140249. Material number 380663-21: Serial numbers: 1311140047, 1311140541, 1311140181, 1311140352 1311140023, 1311140165, 1311140159, 1311140126, 1311140571, 1311140397, 1311140130, 1311140318, 1311140180, 1311140151 1311140375, 1311140428, 1311140528, 1311140263, 1311140169 1311140443, 1311140537, 1311140544, 1311140419, 1311140006 1311140583, 1311140173, 1311140154.
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 a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic 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 labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.

Product Codes/Lot Numbers:

Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424, 1311140196, 1311140146, 1311140252, 1311140010, 1311140289, 1311140578, 1311140435, 1311140349, 1311140411, 1311140389, 1311140156, 1311140198, 1311140452, 1311140186, 1311140554 1311140335, 1311140249. Material number 380663-21: Serial numbers: 1311140047, 1311140541, 1311140181, 1311140352 1311140023, 1311140165, 1311140159, 1311140126, 1311140571, 1311140397, 1311140130, 1311140318, 1311140180, 1311140151 1311140375, 1311140428, 1311140528, 1311140263, 1311140169 1311140443, 1311140537, 1311140544, 1311140419, 1311140006 1311140583, 1311140173, 1311140154.