Reported Oct 8, 2014 · Terminated
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System
- Product UsageThe 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
- Lot codes and dates
- PATIENT SIDE CART, PS4000
- Part Number380652
- Serial Numbers
75 of 75 codes
353668351929354943351749354389351849355824363594361993360419358104357083351852351845361323358107364412364505361994364001349166364112358774359361357082363784353632364343358109358848351052354234354552356258363752354233358775364200359222364619363868354714361989361391361094351853353410355206357698358480365395359223355996363681360417355623365465365839356530364620
- Amount recalled
- 75 devices
Where it was sold
- Nationwide
Why it was recalled
Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
This product could cause temporary or reversible health problems — stop using it.
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