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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 Recall
Patient Side Manipulator
see related information
Date Posted December 03, 2013
Recall Status1 Terminated on February 18, 2014
Recall Number Z-0436-2014
Recall Event ID 66866
Premarket Notification
510(K) Numbers
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 SG235 SG382 SG457 SG546 SG627 SG699 SG031 SG182 SG247 SG387 SG503 SG555 SG629 SG706 SG049 SG194 SG273 SG408 SG504 SG590 SG633 SG712 SG084 SG2020 SG278 SG437 SG507 SG594 SG641 SG751 SG117 SG2024 SG282 SG442 SG523 SG595 SG688 SG781 SG138 SG205 SG329 SG450 SG528 SG607 SG691 SG801 SG161 SG224 SG358 SG454 SG530 SG613 SG698 SG824 SH0584 SH1603 SH1788 SH0628 SH1656 SH1898 SH0999 SH1657 SH1902 SH1075 SH1658 SH1954 SH1108 SH1667 SH1994 SH1340 SH1692 SH1374 SH1720 SH1578 SH1759. International: Australia: SH0689 SH0690 SH1275 SH1278 SH1486 SH1861 SH1875 SH1879 USG319 USG332; Austria: SG579; Belgium: SG430 SH0034 SH1405 SH1406 SH1638; Bulgaria: SH1692; Brazil: SH1768 SG664 SH1866; Canada: SG242 SG345 SH0260 SH0370 SH1095; China: SG815 SG831 SH0965 SH1062 SH1582; Columbia: SH1161; Denmark: SH0975 SH1168 SH1455 SH1716 SH1756; France: SG140 SH0086 SH0372 SH0546 SH0939 SH0971 SH1075 SH1108 SH1639 SH1686 SH1688 SH1740 SH1843 SH1844 USG323 USG798; Germany: SG756 SH0028 SH0593 SH0745 SH0809 SH0924 SH1642 USG106 USG122 USG145 India: SG817 SH0812 SH0968 SH0969 SH1228 SH1229 SH1762: Israel: SH0816; Italy: SG489 SH0148 SH0209 SH0329 SH0757 SH0878 SH0991 SH1587 SH1588 SH1880 SH1881 USG103 USG364 USG398 SG258; Luxembourg: SH1920; Mexico: SH1931 SH1316; Monaco: SH0208; Netherlands: SH0827 SH0923 SH1579 SH1863; Norway: SH0205 SH1159 SH1297 SH1361; Romania: SH0161; Russia: SH1796 SH1868 SH1869 SH1870 SH1871 SH1936; Japan: SG845 SG865 SG893 SG895 SG898 SG901 SH1693 SH1694 SH1696 SH1697 SH1703 SH1704 SH1708 SH1714 SH1722 SH1726 SH1801 SH1802 SH1803 SH1804 SH1819 SH1820 SH1821 SH1829 SH1830 SG862 SH1695 SH1698 SH1700 SH1701 SH1702 SH1705 SH1712 SH1713 SH1715 SH1718 SH1723 SH1724 SH1725 SH1742 SH1800 SH1818 SH1851 SH1858 SH1859 SH1927 SH1832 SH1835 SH1848 SH1849 SH1918 SH1921 SH1929 SH1930 SH1943 USG572; South Korea: SG259 SG435 SG537 SG740 SG883 SH0285 SH0663 SH1845 SH1860 SH1853; Spain: SG2045 SG210 SG796 SG840 SH1443; Sweden: SH1607 SH1608 SH1757 SH1854 SH1874 SH1938 ; Singapore: SH1340 Switzerland: SH0301 SH0553 SH0719 SH1086 SH1103 SH1114; Taiwan: SH0738 SH1121 SH1615 SH1755 SH1758 SH1807 SH1813 Turkey: SG452 SH0251 SH0328 SH1691 SH1779 SH1781 SH1901 United Kingdom: SH0589 SH1000 SH1759 SH1776 SH1806 USG432.
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
For Additional Information Contact Richard Reeves
408-523-2100
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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