—#203868

Product

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K152448
Affected lot / code info: UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

Why it was recalled

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Root cause (FDA determination)

Process control

Action the firm took

On October 24, 2023, Intuitive issued a "Urgent Medical Device Recall notification" to all affected consignees via E.Mail. Intuitive asked consignees to take the following actions: 1. Read and understand the contents of the letter. 2. Locate and return all affected lots of 478115-03 in your inventory via the standard RMA process by calling Intuitive Customer Service based on your region below. 3. Notify all surgeons, personnel, and sites using da Vinci X and da Vinci Xi Single Site Wristed Needle Driver, PN 478115-03 that they should review and understand the contents of this letter. 4. Complete the attached Acknowledgement Form immediately and return it via email to Intuitive as instructed on the form. a. Please retain a copy of this letter and the acknowledgement form for your files. 5. Inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject device via the standard complaint process. 6. For Customers in the US: 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. a. Complete and submit the report Online Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. 8. Inform all affected personnel at your site who use da Vinci procedures when the return has been completed.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea

Timeline

Recall initiated: 2023-10-06
Posted by FDA: 2023-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203868. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.