FDA Device recall Z-0436-2014
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System
- FDA Device
- Class II
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class II recall of Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System by Intuitive Surgical, citing 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 situ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0436-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-11 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | Part number 380900-02 and 380900-03: System ID numbers - US: SH0018 SH0206 SH0407 SH0752 SH0981 SH1179 SH1417…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0436-2014%22
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