Intuitive Surgical, Inc. Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

CA, CO, FL, ID, IL, MI, MS, NJ, NY, OR, SC, TN, TX, PR