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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Xi Surgical System P4 software

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  Class 2 Device Recall da Vinci Xi Surgical System P4 software see related information
Date Initiated by Firm August 17, 2015
Date Posted September 03, 2015
Recall Status1 Terminated 3 on February 08, 2016
Recall Number Z-2734-2015
Recall Event ID 72026
510(K)Number K131861  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
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.
Code Information Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers SK0036 SK0076 SK0119 SK0156 SK0198 SK0250 SK0288 SK0342 SK0395 SK0425 SK0039 SK0077 SK0120 SK0157 SK0203 SK0254 SK0289 SK0346 SK0398 SK0433 SK0046 SK0079 SK0122 SK0159 SK0206 SK0255 SK0291 SK0347 SK0399 SK0434 SK0047 SK0081 SK0123 SK0160 SK0209 SK0257 SK0292 SK0352 SK0400 SK0437 SK0048 SK0087 SK0127 SK0161 SK0211 SK0259 SK0293 SK0356 SK0401 SK0440 SK0049 SK0091 SK0130 SK0162 SK0212 SK0262 SK0294 SK0358 SK0402 SK0441 SK0051 SK0092 SK0134 SK0163 SK0216 SK0263 SK0296 SK0359 SK0404 SK0443 SK0054 SK0093 SK0135 SK0167 SK0225 SK0264 SK0297 SK0360 SK0406 SK0445 SK0057 SK0095 SK0137 SK0168 SK0229 SK0265 SK0298 SK0366 SK0408 SK0448 SK0058 SK0096 SK0138 SK0169 SK0231 SK0266 SK0299 SK0371 SK0409 SK0451 SK0059 SK0098 SK0139 SK0171 SK0233 SK0267 SK0301 SK0375 SK0410 SK0452 SK0061 SK0099 SK0143 SK0173 SK0234 SK0269 SK0302 SK0376 SK0412 SK0455 SK0062 SK0100 SK0144 SK0175 SK0235 SK0270 SK0304 SK0378 SK0414 SK0456 SK0066 SK0101 SK0145 SK0176 SK0236 SK0271 SK0307 SK0382 SK0415 SK0459 SK0067 SK0103 SK0146 SK0178 SK0237 SK0275 SK0309 SK0383 SK0416 SK0463 SK0069 SK0106 SK0147 SK0179 SK0238 SK0276 SK0310 SK0384 SK0417 SK0464 SK0070 SK0113 SK0148 SK0180 SK0239 SK0277 SK0311 SK0385 SK0418 SK0071 SK0114 SK0150 SK0181 SK0242 SK0284 SK0314 SK0389 SK0420 SK0072 SK0115 SK0151 SK0186 SK0243 SK0285 SK0316 SK0390 SK0422 SK0074 SK0116 SK0153 SK0193 SK0245 SK0286 SK0317 SK0394 SK0423.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
408-523-2100
Manufacturer Reason
for Recall		 Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 198 affected devices
Distribution Worldwide Distribution - US Nationwide and in the countries of Italy and Norway.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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