Recall Z-2260-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci SP surgical system
| Date | Jun 3, 2020 (initiated Apr 1, 2019) |
| Status | Terminated |
| Reason | Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback. |
| Root cause | Software design |
| Action | The firm sent a letter to consignees on April 1, 2020 stating that an Intuitive representative will schedule a site visit to provide a software update as soon as possible. Firm representatives will be available by phone to answer any questions related to this Medical Device Correction. Actions taken by the customer are to: Inform all personnel who are involved with the affected device at your site of the following instructions: 1.If vibrations are sensed at the instrument and/or endoscope tips in Adjust Mode and the instrument arm is near its vertical limit: a.Cease applying sustained force ag |
| Quantity | 17 |
| Distribution | U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: 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 |