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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 Posted December 03, 2013
Recall Status1 Terminated 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/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 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
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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