Recall Z-1906-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
| Date | Oct 25, 2018 |
| Status | Terminated |
| Reason | The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier. |
| Root cause | Device Design |
| Action | On 10/25/2018, the firm sent an "Urgent Medical Device Correction" Notification Letter to Customers via FedEx (to OUS customers - emailed and hand-delivered) are asked to take actions during draping to avoid snagging the drape during installation and to continue following the instructions in the System User Manual. Representatives will be available by phone to answer questions related to the device correction. Acknowledgement form included with the recall letter is requested to be completed and returned to ISI asking that appropriate personnel be informed about the device correction. |
| Quantity | 1818 pouches |
| Distribution | Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc., May 31, 2018 |