Recall Z-1484-2022 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
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.
| Date | Jun 22, 2022 |
| Status | Completed |
| Reason | 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. |
| Root cause | 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 hospit |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191280 | E-100 Electrosurgical Generator, SynchroSeal Intuitive Surgical, Inc., Nov 14, 2019 |