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U.S. Department of Health and Human Services

Class 2 Device Recall E100 Generator

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  Class 2 Device Recall E100 Generator see related information
Date Initiated by Firm June 22, 2022
Create Date August 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1484-2022
Recall Event ID 90452
510(K)Number K191280  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.
Code Information Model Number: 374848-09 UDI -DI Code: 00886874116982 System Serial Numbers: SK1521 SK0614 SK4114 SL0615 SL0724 SK1178 SK4098 SL0719 SL0066 SK4353 SK4821 SK4939 SK4099 SL0673 SL0734 SL0736 SK3010 SL0682 SK3857 SK1277 SK4326 SL0666 SK4169 SK4155 SK4327 SK3033 SK1537 SK4100 SK0917 SK4001 SL0581 SK3340 SK4156 SK3870 SL0744 SK1918 SK1227 SK4129 SK4061 SK4152 SK4301 SK4215 SK4217 SL0625 SK4380 SK2459 SK2460 SK0990 SK4146 SK1942 SK1403 SK0071 SK4219 SK4175 SK3391 SK2484 SK1103 SK3389 SK3405 SK0396 SK4254 SK0345 SK4613 SK0821 SK2767 SK3832 SK0549 SK2411 SK1505 SK1837 SK0765 SK4305 SK4081 SK3421 SK4290 SK4145 SK4118 SK4010 SK3066 SK4008 SK2289 SK0788 SK4351 SK4355 SK2076 SK4072 SK4069 SK2608 SL0753 SK4339 SK4282 SK2886 SK0902 SK3833 SK3874 SK2680 SK1494 SK2679 SK3173 SK2245 SK4256 SK4523 SK2209 SK2320 SK3220 SK0682 SK3765 SK4126 SK0679 SK2271 SK1762 SK1848 SK2420 SK1181 SK4180 SK4879 SK2491 SK3941 SK4111 SK1917 SK3917 SK4184 SK4147 SK3707 SK4880 SK3719 SK1594 SK0594 SK1456 SK2120 SK3881 SK1936 SK1935 SK0802 SK0093 SK2028 SK3715 SK4229 SK4211 SK4304 SL0751 SK3388 SK1400 SK0891 SK2066 SK2542 SK1543 SK2945 SK3744 SK4088 SK1581 SK0383 SK1331 SK0650 SK4103 SK1801 SK3277 SK4014 SK3877 SK2461 SK4164 SK3217 SK3902 SK1926 SK1424 SK1101 SK2617 SK4257 SK2280 SK1596 SK3859 SK0757 SK1346 SK0074 SK3888 SK3716 SK2918 SK1993 SK1992 SK1980 SK0261 SK3868 SK1154 SK3442 SK3962 SK3486 SK3958 SK1657 SK3451 SK3495 SK2152 SK1957 SK0729 SK4004 SK3963 SK1311 SK4428 SK1366 SK1856 SK3965 SK2812 SK1370 SK1873 SK1571 SK3971 SK3465 RSK8020 SK1249 SK0812 SK0532 SK1559 SK4134 SK1565 SK3882 SK4235 SK1874 SK3248 SK4263 SK4225 SK4223 SK4221 SK1053 SK0992 SK2283 SK4311 SK3544 SK1681 SK2853 SK1656 SK2147 SK0750 SK1165 SK2732 SK2197 SK1653 SK0438 SK3803 SK4295 SK3774 SK4341 SK3862 SK3708 SL0319 SK1352 RSK8013 SK3073 SK3044 SK3043 SK0607 SK2543 SK1287 SK4307 SK4300 SK0486 RSK8026 RSK8022 RSK8025 SK4068 SK1379 SK2016 RSK8031 SK4284 SK3690 SK3433 SK3936 SK4002 SK2709 SK1317 SK1350 SK0947 SK3373 SK2186 SK4261 SK4259 SK0641 SK4248 SK2757 SL0693 SK4291 SK4258 SK1535 SK4296 SK4198 SK4303 SK4331 SK2306 SK0294 SK3938 SK1107 SK1826 SK1633 SK3829 SK2489 SK4344 SL0086 SK4278 SK0819 SK4743 SK1838 SK1365 SK1205 SK0643 SK1474 SK2629 SK3922 SK3977 SK3896 SK3895 SK4110 SK2473 SK2438 SK3860 SK0198 SK4153 RSK8017 SK4232 SK3827 SK1210 SK4264 SK3983 SK0790 SK2277 SK3359 SK1081 SK1609 SK0700 SK3725 SK3724 SK3798 SK3797 SK3796 SK4120 SL0085 SK3456 SK4266 SK4255 RSK8070 SK3974 SK1144 SK4250 SK0160 SK4005 SK0419 SK4249 SK1492 SK2808 SK1620 SK4218 SK3992 SK4283 SK3942 SK3951 SK4102 SK3028 SK1408 RSK8010 RSK8008 RSK8009 SK2153 RSK8011 SK0437 SK3839 SK0524 SK0380 SK4067 SK4122 SK0638 SK2628 SK3889 SK3713 SK3176 SK1152 SL0416 SK1540 SK1539 SK3932 SK3051 SK4000 SK1930 SK1847 SK4271 SK3704 SK3127 SK1631 SK3892 SK2455 SK1635 SK2953 SK2171 SK0180 SK1009 SK2746 SK2269 RSK8024 SK1407 SK1398 SK4275 SK3712 SK1624 SK0736 SK3770 SK1010 SK0483 SK4285 SK4269 SK3283 SL0558 SK3905 SK3081 SK4347 SK4030 SK2134 SK3873 SK4204 SK0084 SK4657 SK4321 SK1087 SK3562 SK4314 SK2911 SK4035 SK0147 SK1336 SK4233 SK4189 SK0708 SK4244 SK0914 SK2825 SK4194 SK3303 SK1817 SK2163 SK2707 SK3878 SK1902 SK1320 SK2706 SK3546 SK3548 SK1979 SK3737 SK2329 RSK8019 RSK8018 RSK8016 RSK8015 SK4337 SK4230 SK4240 SK1629 SK2418 RSK8085 SK4064 SK1175 SK3756 SK3755 SK0094 SK3771 SK2688 SK0664 SK3542 SK5050 SK4206 SK3557 SK3814 SK2272 SK3229 SK1517 SL0692 SK4728 SL0440 SK1862 SK0181 SK1116 RSK8035 RSK8036 SK2367 RSK8034 SK3813 RSK8038 RSK8039 RSK8030 SK4468 SK2443 SK0298 SK2814 SK3840 SK3379 SK0485 SK1056 SK4041 SK1519 SK0394 SK3961 SK1139 SK3911 SK3914 SK3913 SK3361 SK3912 SK4739 SK1890 SK3915
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact Alex Mathews
408-523-2100
Manufacturer Reason
for Recall		 Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
FDA Determined
Cause 2		 Process design
Action On 06/20/2022, the firm sent out an "Medical Device Correction" letter via US direct Mail to customers informing them that the firm became aware that certain testing requirements were not performed during the annual preventative maintenance process for certain E-100 Generators. Specifically, output power calibration, to confirm adherence to specifications for energy delivery to compatible devices, and electrical safety testing, to ensure electrical isolation and ground connection. Customers are instructed that they can continue to use the E-100 Generators and to: 1. Notify all affected hospital personnel about this Medical Device Correction. 2. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 3. Please retain a copy of this letter and the acknowledgement form for their files. 4. Please inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. 5. Additionally, if Adverse Events*/Serious Incidents** or quality problems are experienced, please follow your standard reporting process to your health authority, if applicable. 6. Notify affected personnel when the affected product has been replaced by the Intuitive representative. For questions or further assistance: - US, Puerto Rico and Dominican Republic (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com - Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com
Quantity in Commerce 505 generators
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of Belgium, Denmark, Germany, Japan, Italy, Monaco, Norway, Sweden, Switzerland, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical, Inc.
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