Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
FDA device recall Z-1518-2024 · posted 2024-04-11 · Open, Classified
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- 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.
- Action taken
- 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 support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Firm Customer Service: - North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or eucs@intusurg.com - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NAY
- Quantity affected
- 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
- Date initiated
- 2024-03-13
- Date posted
- 2024-04-11
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K182371) | Intuitive Surgical, Inc. | 2019-03-14 |
| da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K173906) | Intuitive Surgical, Inc. | 2018-05-31 |