Recall Z-1518-2024— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2024-03-13. It names 2 FDA 510(k) clearances: K182371, K173906. Product: Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098. 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..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-13
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K182371 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.