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Terminated

da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) 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, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave 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.

FDA Recall Z-2341-2018 · Posted None

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2018-03-07
Date Terminated2020-07-29
Product Quantity108 ACJ's on 35 surgical systems

Reason for Recall

Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.

Firm Action

Intuitive Surgical, Inc. sent a Recall letters dated 3/7/2018 to affected customers via FedEx. The letter identified the affected product problem, risk to health, affected serial numbers, the action the firm will be taking, and the actions to be taken by the customer.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide AR, CA, FL, GA, IL, IA, MN, MS, NE, OK, TN, and TX. Foreign distribution was made to Australia, Austria, Finland, France, Germany, Italy, Netherlands, Spain, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171294da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2017-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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