FDA Device recall Z-1568-2016
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software by Intuitive Surgical, citing potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitionin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1568-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-25 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: 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.
Reason
Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
Identifiers
| code_info | da Vinci systems with serial numbers: SK0036 SK0292 SK0650 SK0039 SK0293 SK0652 SK0057 SK0294 SK0653 SK0101…da Vinci systems with serial numbers: SK0036 SK0292 SK0650 SK0039 SK0293 SK0652 SK0057 SK0294 SK0653 SK0101 SK0326 SK0654 SK0106 SK0358 SK0665 SK0119 SK0360 SK0701 SK0143 SK0382 SK0702 SK0144 SK0408 SK0710 SK0146 SK0438 SK0722 SK0171 SK0456 SK0728 SK0173 SK0484 SK0181 SK0492 SK0216 SK0496 SK0230 SK0516 SK0233 SK0548 SK0237 SK0552 SK0238 SK0610 SK0263 SK0612 SK0286 SK0631 SK0291 SK0649. |
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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-1568-2016%22
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