—#164959

Product

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 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 S/N SL0008, ACJ S/N's P117154256, P117154263, P117154281, P117154286; System S/N SL0012, ACJ S/N's P117154260, P117154297, P117154298, P117154308; System S/N SL0013, ACJ S/N's P117154251, P117154255, P117154257, P117154305; System S/N SL0015, ACJ S/N's P117154274, P117154276, P117154289, P117154290; System S/N SL0016, ACJ S/N's P117154259, P117154291, P117154306, P117154307; System S/N SL0017, ACJ S/N's P117154261, P117154269, P117154277, P117154296; System S/N SL0018, ACJ S/N's P117194009, P117194017, P117194037; System S/N SL0019, ACJ S/N's P117154267, P117154283, P117154294, P117154302; System S/N SL0020, ACJ S/N's P117194008, P117194050, P117194060, P117194078; System S/N SL0021, ACJ S/N's P117194063, P117194064, P117194081, P117194083; System S/N SL0028, ACJ S/N's P117154279, P117154285, P117154292, P117154300; System S/N SL0034, ACJ S/N's P117154264, P117154275, P117154304; System S/N SL0035, ACJ S/N's P117194016, P117194019, P117194070, P117194093; System S/N SL0036, ACJ S/N's P117194025, P117194073, P117241990; System S/N SL0037, ACJ S/N's P117194006, P117194036, P117194056, P117194058 System S/N SL0038, ACJ S/N's P117241971, P117241993; System S/N SL0039, ACJ S/N's P117194013, P117194024, P117194031, P117194032; System S/N SL0040, ACJ S/N's P117194046, P117194061, P117194088, P117194094; System S/N SL0041, ACJ S/N's P117194027, P117194040, P117194043, P117194049; System S/N SL0042, ACJ S/N's P117154288, P117194015, P117194052, P117194090; System S/N SL0043, ACJ S/N P117241988; System S/N SL0044, ACJ S/N's P117194007, P117194085, P117241978; System S/N SL0045, ACJ S/N's P117241965, P117241970, P117241982, P117241984; System S/N SL0046, ACJ S/N's P117194014, P117241964, P117241976, P117241980; System S/N SL0047, ACJ S/N's P117194020, P117194048, P117194067, P117194074 System S/N SL0048, ACJ S/N's P117194004, P117194072, P117200171; System S/N SL0052, ACJ S/N's P117241977, P117241979, P117241986, P117241991; System S/N SL0053, ACJ S/N P117241966; System S/N SL0055, ACJ S/N P117283217; System S/N SL0056, ACJ S/N P117283216; System S/N SL0060, ACJ S/N P117241972; System S/N SL0063, ACJ S/N P117241968; System S/N SL0070, ACJ S/N's P117194028, P117194092; System S/N SL0071, ACJ S/N's P117194018, P117283218; and System S/N SL0073. ACJ S/N P117283214.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2018-03-07
Terminated: 2020-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164959. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.