Class 2 Device Recall da Vinci SP Camera

• Date Initiated by Firm: August 19, 2019
• Create Date: June 01, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2131-2020
• Recall Event ID: 85324
• 510(K)Number: K173906
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
• Code Information: Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: 408-523-2100
• Manufacturer Reason for Recall: Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
• FDA Determined Cause: Process control
• Action: Urgent Medical Device Recall Letters (Field Safety Notices) were hand-delivered to U.S. customers on August 19, 2019 and OUS customers on August 20, 2019. Customers were asked to locate affected camera(s) in their inventory and inspect per the instructions attached to the Field Safety Notice throughout the life of the camera(s). If residual soil is present, customers were to return the affected camera(s) to the manufacturer using the standard Return Materials Authorization (RMA) process. Additionally, customers were requested to: iInform necessary hospital personnel about this issue; complete the attached Acknowledgement Form and return it via fax to Intuitive as instructed on the form; and to retain a copy of this letter and the Acknowledgement Form for their files. Customers were informed that an Intuitive Representative would schedule a site visit to review the attached inspection instructions, and that the firm will provide a replacement camera, at no charge, for returned affected product. Customers requiring further information or support may contact their Clinical Sales Representative or contact Intuitive Customer Service at the following numbers: US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com, or South Korea Customer Service: + 82-02-3271-3200, Option 3 ( 9AM to 6 PM KSTJ)
• Quantity in Commerce: 305 units
• Distribution: Distribution US nationwide and South Korea.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY