Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Int

Recalled September 9, 2015 · FDA recall Z-2734-2015 · Intuitive Surgical

Hazard

Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software. · FDA Class II

Units

198 affected devices

Sold at

Worldwide Distribution - US Nationwide and in the countries of Italy and Norway.

Description

Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.

Product

da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic 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 thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.

Manufacturer(s)

Intuitive Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →