Clarification Regarding December 2024 Customer Communication
We have recently become aware of mischaracterizations regarding a December 2024 Intuitive communication to US customers. This post provides accurate information and technical clarification regarding this communication.
Power Outage Preparedness
Severe weather, backup generator testing, or excessive power demand can cause power outages or fluctuations, unrelated to Intuitive’s da Vinci surgical systems.
After Intuitive became aware of a limited number of hospitals experiencing repeated wall-power outlet interruptions, we issued a December 2024 communication to reiterate existing best practices for managing da Vinci 5 surgical systems during broader institutional power outages or fluctuations. These are consistent with, and already described in, da Vinci 5’s FDA-cleared Instructions for Use (IFU).
The December 2024 communication did not identify new hazards, device malfunctions or unanticipated failure modes, nor did it introduce new operating requirements. The letter reinforced appropriate actions in response to external power conditions outside of Intuitive’s surgical systems, and aligned with the IFU.
The da Vinci 5 Surgical System is designed and tested in accordance with applicable electrical safety and electromagnetic compatibility standards. The system performs as intended when supplied with stable power consistent with the IFU.
Software Update Details
Following our December 2024 customer communication, and while Intuitive’s da Vinci 5 surgical system continued to perform to specification when a consistent power supply was provided as described in our IFU, we implemented software enhancements to help customers better address this topic.
These enhancements were preventative and incremental in nature and were implemented to improve robustness rather than to address any newly identified safety concern. There have been zero related complaints since release of our latest software update (out of more than 36,000 procedures performed).
Commitment to Safety and Compliance