Intuitive Surgical Recalls da Vinci Xi 8mm Endoscopes for Safety Manual Correction
Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to prevent unintended patient harm from capacitive coupling when using 8mm endoscopes with specific instruments.
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: The recall is classified as FDA Class II and involves a risk of unintended patient harm from capacitive coupling, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is issuing a correction to the da Vinci Xi I&A User Manual regarding the use of 0-degree, 8mm endoscopes (Model numbers: 470026-34, 470026-40, 470026-41). The correction provides guidance on the proper use of these endoscopes in combination with da Vinci 8mm and 12mm cannulae, cannula reducers, and monopolar energy instruments.
The recall is necessary to inform customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources. The affected devices are the 0-degree, 8mm Endoscopes, IS4000, which produce high-definition visible light video processed by the system electronics in the Vision Cart.
A total of 2,624 units across all affected models were distributed worldwide, including the United States and various international locations. The recall is classified as FDA Class II. Users should refer to the corrected manual for proper usage protocols to mitigate the risk of capacitive coupling.
The recalled product
- Product
- 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on th
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 2,624
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model numbers: 470026-34
- 470026-40
- 470026-41. All lots.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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