—#206739

Product

Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K173906, K182371
Affected lot / code info: Part/UDI-DI: 380601/00886874114605. SP1098 Serial Numbers: SP0202, SP0253, SP0254, SP0219, SP0228, SP0231, SP0238, SP0273, SP0208, SP0226, SP0240, SP0247, SP0249, SP0256, SP0257, SP0268, SP0270, SP0272, SP0221, SP0223, SP0225, SP0229, SP0230, SP0232, SP0233, SP0235, SP0236, SP0237, SP0239, SP0241, SP0242, SP0243, SP0244, SP0245, SP0248, SP0250, SP0251, SP0252, SP0255, SP0258, SP0259, SP0260, SP0261, SP0262, SP0263, SP0264, SP0265, SP0266, SP0269, SP0274, SP0278, SP0280, SP0282

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2024-03-13
Posted by FDA: 2024-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206739. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.