—#218633

Product

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369
Affected lot / code info: Lot Code: 420183, Permanent Cautery Hook GTIN: 00886874111536 FDA Medical Device Listing Number: D088920 Material Numbers: 420183-05 System Numbers: USG294 SH0059 SH0075 SH0059 USG294 Material Number: 420183-06 da Vinci System Numbers: SH1378 SH1378 SH0729 SH1182 USG294 USG294 USG294 SH1015 SH0729 USG294 SH0825 SH1390 SG704 SH0935 SG704 USG022 SH1182 SH0729 SH1390 SH1276 USG294 SH1182 SG704 SH1182 SH1276 SH1076 USG294 SH1015 SH1076 SH1390 USG022 SH2144 SH1182 SH0825 SH1182 SH0547 USG689 SH1385 USG689 USG294 SH1276 SH1076 SH1276 SH0729 SH0059 SH1604 SH0825 USG294 SH1276 SH1378 SH1622 SH1182 SH0059 SH1182 SH1276 SH1276 USG689 USG294 SH1182 SH1276 SH1378 USG518 SH1182 SH1570 SH1276 SH1182 SH0035 SH0825 SH0035 SH1837 SH1276 USG294 SH0059 SH1368 SH1276 SH1570 SH1378 SH1182 SH1378 SH1378 SH0547 SH1276 SH1276 USG518 SH1276 SH1182 SH1015 SH0495 SH1182 SH1390 SH1378 SH1182 SH1276 SH0825 SH1378 SG704 SH1378 SH1276 SH1182 SH0547 SH0935 SH0547 SH1622 SH1182 SH1557 USG294 SH0495 SH1276 SH1557 SH1276 SH1182 SH1391 SH1276 SH1557 SH2186 SH1182 SH1391 SH1182 SH1997 USG294 SH1997 SH2125 SH1276 SH2125 SH1276 SH1182 Material Number: 420183-10 da Vinci System Numbers: SH1182 SH0825 SH1276 SH1182 SH2125 SH1182 USG294 USG294 SH1182 SH1182 SH0547 SH1378 SH0495 SH1182 SH1997 SH1182 SH1276 SH0825 USG518 SH1182 SH1276 SH1276 SH2125 SH0825 SH1182 SH1182 SH1837 SH0935 SH2144 SH0935 SH2125 SH1182 SH1378 SH0935 SH1276 SH1182 SH1622 SH1390 SH2125 SH1557 SH1182 SH1368 SH0935 SH1557 SH1182 SH0495 SH2125 SH0935 SH1182 SH0547 SG704 SH1182 SH1279 SH1557 SH0825 SH2125 SH1076 Material Number: 420183-11 da Vinci System Numbers: SH1390 SH1182 SH2125 SH1557 SG704 SH1015 USG294 SH1015 SH1182 SH1182 USG294 SH1182 SH0935 SH0935 SH1390 SH2125 SH1182 SH1570 SH1182 SH1015 SH2125 USG294 SH1076 SH1378 SH1557 USG689 USG022 SH0035 SH0059 SH1390 SH2125 SH0935 SH1182 SH1015 SH1182 SH1604 SH2125 SH1182 SH1015 SH1182 SH1622 SH1182 SH0059 SH1015 SH1015 SH0935 SH0935 Material Number: 420183-12 da Vinci System Numbers: SH1390 SH2125 SH1182 SH0935 SH1182 SH0059 SH1015 SH0935 SH2125 SH1182 USG518 USG294 SH1182 SH2125 SH1182 SH1570 SH1182 SH1182 SG704 SH2125 SH1182 SH1557 SG704 SH1182 USG294 SH1557 SH2125 USG294 SH1182 SH1557 SH2125 SH0935 SH0825 SH0729 SH1182 SH1557 SH0059 SH1622 SH1182 USG294 SH1378 SH1557 SH2125 SH1076 SH1822 USG294 SH1182 SH1557 SH0825 SH1182 SH0495 SH2125 SH1557 SH2144 SH2125 SG704 SH0059 SH2125 SH1604 Material Number: 420183-14 da Vinci System Numbers: SH1182 SH2125 SH1182 SH2144 SH2144 USG294 SH1622 SH2125 SH1182 SH1182 SH1822 SH2125 USG721 SH0729 SH1822 SG704 SH2125 SH0825 SH1015 SH1182 SH1182 SH2125 SH1997 SH1622 SH0825 SH2186 SH2180 SH1822 SH0729 SH1015 SH1015 SH2144 SH1822 SH2125 USG721 SH1182 SH1182 SH1997 USG294 SH2186 SH1182 SH0495 SH1997 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Numbers: 420183-16 da Vinci System Number: SH1997

Why it was recalled

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Root cause (FDA determination)

Process change control

Action the firm took

On 12/29/2025, the firm email and sent via overnight priority mail an "Urgent: Medical Device Recall" letter to customers informing them of possible pitch cable failures on the da Vinci S and Si Tenaculum Forceps and Permanent Cautery Hooks reusable instruments. Customers are instructed to: 1. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 2. Please identify and quarantine any affected product(s). Affected product(s) listed above may be returned by sending an email with quantities and lot numbers to your regional customer service. 3. Please ensure to include the FSCA number ISIFA2025-16-R in your return notes. 4. Credit will be provided based on the number of remaining lives. 5. If affected products were shared or further distributed with other sites, make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product. 6. Please retain a copy of this letter and the acknowledgement form for your files. 7. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. For further information or support, contact Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: " 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 " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)

Recalling firm

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

Distribution

Distribution pattern: U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Timeline

Recall initiated: 2025-12-09
Posted by FDA: 2026-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218633. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.