FDA Device recall Z-1377-2016
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System… by Intuitive Surgical, citing intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardia….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1377-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-16 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Reason
Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
Identifiers
| code_info | Model number 551457- IS4000 English: Model number 551706 - IS4000 OUS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1377-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.