da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.
FDA Recall Z-3254-2018 · Posted None
Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2018-07-16
Date Terminated2023-10-05
Product Quantity1,014 currently installed on systems
Reason for Recall
Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
Firm Action
On 07/16/2018, the firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" Notification to customers vi a Federal Express and email, and posted on the US Customer Portal . The letter described the product, problem and actions to be taken. The notice states to note that solely having the affected power supply module does not mean the system will encounter a power loss event. To encounter the related power loss scenario above, both of the following two (2) conditions must be met.
1. The system contains the affected power supply.
2. A failure of one of the power supply modules is experienced.
The notice instructs customers to follow their specific system user manuals for guidance on how to proceed in the scenario where a loss of power is experienced on a console or cart. If the failure occurs to the Surgeon Console and the site has a dual console set up, the site may continue with the planned surgery robotically with one console.
To correct this issue, an Intuitive Surgical Representative will schedule a site visit to provide a replacement RMGSP.
The notice also instructs customer/user to, please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures.
1. You may continue using the system until the Intuitive Surgical representative replaces the unit. Please follow your specific system user manuals for guidance on how to proceed in the scenario where a loss of power is experienced on a console or cart.
2. Ensure surgeons and patient side assistants using the da Vinci Si, Xi, and X Surgical System read and understand the contents of this letter.
3. Inform affected personnel when corrective action has been completed.
4. Complete the attached Acknowledgement Form and return it via fax or email to Intuitive Surgical per the instr
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, Norway, New Zealand, Romania, Russia, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.