Events

Recall of Device Recall INSTRUMENT ARM DRAPE, IS4000, 20 PACK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71448
  • Event Risk Class
    Class 2
  • Event Number
    Z-1949-2015
  • Event Initiated Date
    2015-06-16
  • Event Date Posted
    2015-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137832
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System,surgical,computer controlled instrument - Product Code NAY
  • Reason
    Field safety notification to advise of an issue that may occur involving the combination of the da vinci xi drapes and xi instruments. a pinched drape may cause a message on the vision cart touchscreen - missing reload error.
  • Action
    Intuitive Surgical sent an Urgent Medical Device Notification letter on June 16 , 2015 to all affected consignees. Consignees were instructed to take the following actions: 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures. 2. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 3. Please retain a copy of this notice with your system. 4. Refer to the da Vinci Xi System User Manual for more information on draping the system. Consignees with questions or needing spport should contact their Clinical Sales Representative or contact Intuitive Surgical Sustomer Service at the numbers listed below: Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: ¿ North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com ¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) ¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST) .

Device

Device Recall INSTRUMENT ARM DRAPE, IS4000, 20 PACK
  • Model / Serial
    Manufacturing lot numbers: 470015-05, 470015-06. System numbers: SK0194 SK0312 SK0182 SK0195 SK0313 SK0241 SK0321 SK0131 SK0117 SK0149 SK0068 SK0197 SK0329 SK0185 SK0183 SK0253 SK0142 SK0141 SK0078 SK0128 SK0224 SK0192 SK0381 SK0085 SK0086 SK0247 SK0109 SK0088 SK0199 SK0200 SK0201 SK0215 SK0223 SK0336 SK0164 SK0256 SK0202 SK0214 SK0089 SK0165 SK0374 SK0374 SK0124 SK0260 SK0323 SK0252 SK0319 SK0327 SK0373 SK0335 SK0129 SK0184 SK0229 SK0110 SK0111 SK0350 SK0351 SK0136 SK0132 SK0190 SK0290 SK0158 SK0207 SK0341 SK0246 SK0226 SK0187 SK0232 SK0303 SK0328 SK0330 SK0315 SK0334 SK0204 SK0248 SK0344 SK0322 SK0219 SK0353 SK0222 SK0154 SK0318 SK0217 SK0196 SK0221 SK0172 SK0218 SK0220 SK0379 SK0213 SK0108 SK0177 SK0179 SK0101 SK0170 SK0233 SK0309 SK0234 SK0235 SK0105 SK0104 SD0002 SK0240 SK0360 SK0203 SK0091 SK0106 SK0206 SK0326 SK0294 SK0291 SK0237 SK0293 SK0238 SK0292 SK0272 SK0273 SK0356 SK0148 SK0095 SK0347 SK0135 SD0001 SK0259 SK0167 SK0371 SK0152 SK0087 SK0159 SK0225 SK0069 SK0099 SK0257 SK0178 SK0061 SK0343 SK0064 SK0163 SK0065 SK0180 SK0346 SK0285 SK0348 SK0280 SK0383 SK0239 SK0209 SK0258 SK0352 SK0331 SK0308 SK0271 SK0264 SK0358 SK0216 SK0039 SK0263 SK0162 SK0270 SK0059 SK0120 SK0143 SK0144 SK0279 SK0338 SK0265 SK0267 SK0051 SK0266 SK0316 SK0339 SK0145 SK0139 SK0074 SK0255 SK0314 SK0147 SK0186 SK0082 SK0295 SK0174 SK0055 SK0119 SK0058 SK0134 SK0242 SK0333 SK0250 SK0342 SK0302 SK0084 SK0092 SK0166 SK0090 SK0269 SK0114 SK0113 SK0375 SK0268 SK0296 SK0299 SK0168 SK0324 SK0300 SK0245 SK0083 SK0231 SK0287 SK0098 SK0298 SK0198 SK0275 SK0067 SK0066 SK0096 SK0254 SK0103 SK0230 SK0208 SK0070 SK0093 SK0332 SK0205 SK0044 SK0301 SK0094 SK0278 SK0286 SK0075 SK0317 SK0137 SK0349 SK0284 SK0122 SK0138 SK0146 SK0249 SK0320 SK0057 SK0228 SK0210 SK0079 SK0176 SK0155 SK0150 SK0156 SK0097 SK0307 SK0157 SK0288 SK0304 SK0244 SK0054 SK0123 SK0188 SK0189 SK0072 SK0175 SK0193 SK0062 SK0100 SK0382 SK0376 SK0173 SK0297 SK0261 SK0181 SK0063 SK0130 SK0359 SK0274 SK0112 SK0140 SK0262 SK0036 SK0236 SK0050 SK0378 SK0169 SK0081 SK0076 SK0345 SK0077 SK0380 SK0310 SK0211 SK0277 SK0276 SK0071 SK0227 SK0153 SK0048 SK0191 SK0289 SK0046 SK0127 SK0340 SK0160 SK0047 SK0049 SK0161 SK0171 SK0311 SK0073 SK0151 SK0325 SK0243 SK0115 SK0116 SK0212.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. || 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.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    USFDA