Recall Z-1518-2024 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
| Date | Apr 11, 2024 (initiated Mar 13, 2024) |
| Status | Open, Classified |
| Reason | Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient. |
| Root cause | Nonconforming Material/Component |
| Action | On 3/13/24, Field Safety Notices were mailed and emailed to customers who were asked to do the following: 1) To prevent a pinch injury, please use two people when attempting to move the EGM in an unpowered state. 2) Inform necessary hospital personnel about this issue and affected personnel when the requested actions have been completed. 3) Complete and return the response form via email to Recalls@intusurg.com A firm representative will schedule a site visit to perform the inspection of the Link 2 EGM belts of the affected population of SP systems. If you need further information or su |
| Quantity | 53 |
| Distribution | US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea |
| FDA record | Open on fda.gov |