PlainRecalls
FDA Devices Moderate Class II Terminated

da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. 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 mani

Reported: April 1, 2015 Initiated: March 3, 2015 #Z-1302-2015

Product Description

da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. 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.

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.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
167 total da Vinci Xi affected systems
Distribution
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. 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.. Recalled by Intuitive Surgical, Inc.. Units affected: 167 total da Vinci Xi affected systems.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 1, 2015. Severity: Moderate. Recall number: Z-1302-2015.