The Recall Desk
HighFDA (Devices)·Z-0653-2016·Announced 2016-01-20

Intuitive Surgical Recalls da Vinci Xi Endoscopes for Capacitive Coupling Risk

Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to warn about unintended patient harm from capacitive coupling when using 8 mm 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 involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Intuitive Surgical, Inc. is issuing a correction to the da Vinci Xi I&A User Manual regarding the use of da Vinci Xi 8 mm Endoscopes. This correction addresses the combination of these endoscopes with da Vinci 8 mm and 12 mm 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 products are the 30 degree, 8 mm Endoscope, IS4000, with model numbers 470027-34, 470027-40, and 470027-41. A total of 2,624 units across all models are involved in this recall.

The affected devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Australia, Austria, Belgium, and the United Kingdom. Healthcare providers and customers should review the corrected user manual to understand the proper use of these instruments and avoid scenarios that could lead to patient injury.

The recalled product

Product
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. 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 t
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Endoscope
Hazard
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: 470027-34
  • 470027-40
  • 470027-41. All lots.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 2 products in this recall →

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