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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Side Manipulator

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  Class 2 Device Recall Patient Side Manipulator see related information
Date Initiated by Firm November 11, 2013
Date Posting Updated December 03, 2013
Recall Status1 Terminated 3 on February 18, 2014
Recall Number Z-0436-2014
Recall Event ID 66866
510(K)Number K050369  K081137  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Assembly, Patient Side Manipulator on da Vinci Surgical Systems:
da Vinci S Surgical System;
da Vinci SI Surgical System
da Vinci Si-e Surgical System;

Manufactured by Intuitive Surgical
Sunnyvale, CA 94086.

The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electro cautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electro cautery, 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 cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use
Code Information Part number 380900-02 and 380900-03:, System ID numbers - US: , SH0018, SH0206, SH0407, SH0752, SH0981, SH1179, SH1417, SH1690, SH1785, SH1887, SH0022, SH0214, SH0408, SH0755, SH0983, SH1180, SH1418, SH1699, SH1786, SH1889, SH0025, SH0216, SH0409, SH0756, SH0987, SH1186, SH1430, SH1706, SH1787, SH1890, SH0030, SH0223, SH0414, SH0762, SH0989, SH1191, SH1437, SH1707, SH1789, SH1891, SH0032, SH0226, SH0423, SH0765, SH0994, SH1194, SH1441, SH1709, SH1790, SH1892, SH0036, SH0228, SH0427, SH0769, SH0997, SH1199, SH1445, SH1710, SH1791, SH1893, SH0038, SH0232, SH0428, SH0770, SH1007, SH1201, SH1448, SH1711, SH1792, SH1894, SH0040, SH0240, SH0431, SH0772, SH1011, SH1203, SH1459, SH1719, SH1793, SH1896, SH0042, SH0243, SH0436, SH0781, SH1012, SH1215, SH1461, SH1721, SH1794, SH1897, SH0049, SH0245, SH0437, SH0791, SH1013, SH1246, SH1507, SH1727, SH1795, SH1899, SH0053, SH0248, SH0438, SH0808, SH1014, SH1259, SH1517, SH1728, SH1797, SH1900, SH0055, SH0254, SH0439, SH0819, SH1016, SH1269, SH1518, SH1729, SH1798, SH1903, SH0057, SH0258, SH0448, SH0821, SH1024, SH1269, SH1531, SH1731, SH1808, SH1904, SH0060, SH0262, SH0453, SH0823, SH1027, SH1273, SH1539, SH1733, SH1809, SH1905, SH0065, SH0265, SH0454, SH0829, SH1029, SH1283, SH1564, SH1735, SH1810, SH1906, SH0066, SH0266, SH0466, SH0838, SH1030, SH1285, SH1580, SH1736, SH1811, SH1907, SH0067, SH0268, SH0473, SH0845, SH1031, SH1286, SH1581, SH1739, SH1812, SH1908, SH0068, SH0272, SH0475, SH0847, SH1032, SH1288, SH1583, SH1741, SH1814, SH1909, SH0070, SH0275, SH0489, SH0849, SH1034, SH1290, SH1589, SH1743, SH1815, SH1910, SH0076, SH0282, SH0490, SH0850, SH1036, SH1293, SH1594, SH1744, SH1817, SH1912, SH0078, SH0284, SH0493, SH0853, SH1050, SH1294, SH1598, SH1746, SH1822, SH1913, SH0082, SH0292, SH0521, SH0855, SH1053, SH1306, SH1599, SH1747, SH1823, SH1915, SH0085, SH0296, SH0524, SH0858, SH1055, SH1322, SH1605, SH1748, SH1824, SH1916, SH0108, SH0304, SH0525, SH0862, SH1059, SH1324, SH1606, SH1749, SH1827, SH1922, SH0112, SH0309, SH0527, SH0865, SH1069, SH1331, SH1612, SH1750, SH1831, SH1923, SH0113, SH0310, SH0543, SH0866, SH1080, SH1332, SH1617, SH1752, SH1840, SH1924, SH0115, SH0314, SH0548, SH0867, SH1081, SH1333, SH1629, SH1753, SH1841, SH1925, SH0134, SH0318, SH0557, SH0871, SH1082, SH1334, SH1630, SH1754, SH1842, SH1926, SH0141, SH0319, SH0577, SH0873, SH1085, SH1335, SH1631, SH1760, SH1846, SH1933, SH0145, SH0326, SH0585, SH0875, SH1091, SH1336, SH1632, SH1761, SH1847, SH1934, SH0147, SH0327, SH0592, SH0877, SH1096, SH1337, SH1633, SH1763, SH1850, SH1935, SH0149, SH0330, SH0619, SH0883, SH1099, SH1343, SH1634, SH1764, SH1855, SH1942, SH0157, SH0331, SH0633, SH0886, SH1110, SH1347, SH1635, SH1765, SH1856, SH1952, SH0160, SH0332, SH0644, SH0904, SH1120, SH1363, SH1636, SH1766, SH1857, SH1955, SH0165, SH0335, SH0653, SH0905, SH1124, SH1365, SH1645, SH1767, SH1862, SH0167, SH0341, SH0670, SH0920, SH1125, SH1367, SH1646, SH1769, SH1864, SH0171, SH0343, SH0684, SH0925, SH1131, SH1370, SH1650, SH1770, SH1865, SH0172, SH0344, SH0695, SH0928, SH1132, SH1371, SH1651, SH1771, SH1867, SH0180, SH0355, SH0700, SH0932, SH1133, SH1372, SH1655, SH1772, SH1872, SH0181, SH0374, SH0710, SH0936, SH1134, SH1375, SH1658, SH1773, SH1873, SH0182, SH0378, SH0717, SH0942, SH1137, SH1376, SH1665, SH1774, SH1876, SH0183, SH0384, SH0722, SH0946, SH1139, SH1381, SH1669, SH1775, SH1877, SH0184, SH0385, SH0723, SH0949, SH1142, SH1386, SH1670, SH1777, SH1878, SH0187, SH0390, SH0731, SH0962, SH1157, SH1390, SH1673, SH1778, SH1882, SH0190, SH0391, SH0734, SH0966, SH1165, SH1396, SH1679, SH1780, SH1883, SH0196, SH0398, SH0739, SH0972, SH1170, SH1400, SH1680, SH1782, SH1884, SH0198, SH0401, SH0748, SH0973, SH1177, SH1401, SH1683, SH1783, SH1885, SH0202, SH0403, SH0751, SH0976, SH1178, SH1402, SH1689, SH1784, SH1886, USG008, USG077, USG113, USG166, USG013, USG092, USG114, USG168, USG020, USG093, USG136, USG169, USG044, USG095, USG146, USG170, USG050, USG104, USG151, USG172, USG074, USG105, USG156, USG180, SG014, SG163, SG
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
Manufacturer Reason
for Recall
Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.
FDA Determined
Cause 2
Device Design
Action The firm, Intuitive Surgical, sent an "Urgent Medical Device Recall" letter dated November 11, 2013 all affected customers via traceable mail. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: 1. Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to all Surgeons and OR staff who perform da Vinci surgical procedures, Risk Manager, OR Director, Purchasing, and Biomedical Engineering staff. 2. Complete the attached Acknowledgement Form and return it to Intuitive Surgical via Fax to: Intuitive Surgical, Inc., ATTN: REGULATORY AFFAIRS U.S. +1 (408) 716-3040, or Scan and Email: isi.compliance@intusurg.com. 3. An Intuitive Surgical Representative will contact your site to schedule the inspection of the instrument arms on your system(s) as indicated above. Please work with the Intuitive Surgical Representative to schedule this activity. 4. Please inform appropriate personnel when the correction has been completed. 5. Please retain a copy of this letter and the Acknowledgement Form for your files. If you need further information or support concerning this medical device correction, then please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below. ¿ North and South America: 800-876-1310 Option 3 (6 am to 5pm PST) ¿ Japan: 0120-56-5635 or 03-5575-1362 (9am to 6pm JST) ¿ South Korea: 02-3271-3200 (9am to 6pm KSTJ) ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET).
Quantity in Commerce 1,386
Distribution Worldwide Distribution: US (nationwide) and to countries of: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Denmark, France, Germany, India, Israel, Italy, Japan, S. Korea, Luxembourg, Mexico, Monaco, Netherlands, Norway, Romania. Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.