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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 235
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 CA 94086-5304
408-523-2100
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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