Recall Z-1484-2022
Intuitive Surgical, Inc. · initiated June 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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: Process design
Action taken
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
Details
- Recall number
- Z-1484-2022
- Initiated
- June 22, 2022
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 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.
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA