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Terminated

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.

FDA Recall Z-1568-2016 · Posted None

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2016-03-25
Date Terminated2016-07-01
Product Quantity43

Reason for Recall

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.

Firm Action

Intuitive Surgical sent an Urgent Product Safety notification to customers via e-mail on March 25, 2016. Customers were advised to STOP USE on the EndoWrist Stapler 45 and 30 instruments on da Vinci XI systems with p5 software. Product letters followed and were mailed on March 31, 2016 by Fed Ex. Urgent Medical Device letters were sent via Fed Ex on March 31, 2016 (dated April 1, 2016). These letters reiterated what was explained in the previous e-mail and provide more information of the unexpected motion issue. In addition to the stop use request, letters requested that all personnel be fully informed of the issue. Further information or support concerning this issue, please contact your Clinical Sales Representative or contact ISI Customer Service at the number: North America: 800-876-1310 Option 3 (6 am to 5pm PST)

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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