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.
FDA Recall Z-2734-2015 · Posted 2015-09-03
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2015-08-17
Date Terminated2016-02-08
Product Quantity198 affected devices
Reason for Recall
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
Firm Action
Intuitive sent an Urgent Medical Device Correction letters dated August 21, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Clinical Sales or ISI Customer service at 800-876-1310 Option 3.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide and in the countries of Italy and Norway.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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