Da Vinci 5 tower may unintentionally activate the infrared handheld camera
The Da Vinci 5 system tower is being corrected because the near infrared handheld camera can be unintentionally activated when a user tries to turn off illumination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a light source may activate unintentionally during surgery, a risk of harm with no injuries reported in the source.
Plain-English summary
The Da Vinci 5 system tower, ASSY,DV5 TOWER,IS5000, part number 380746, UDI 00886874119662, is subject to a correction. The action covers 1,357 systems.
The issue arises from unintentional activation of the near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope. The FDA classified the action as Class II.
Distribution was nationwide in the United States across a large number of states. The systems are installed in hospital operating rooms rather than sold to consumers.
Facilities should identify affected systems using the part number and UDI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integ
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,357
Distribution
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