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Recall Observatory FDA recall evidence

Device product

The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

Z-2835-2018

May 17, 2018

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 80691
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2835-2018

Official wording

Reason: An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.

Code information: UDI Number: 00886874114193. Serial Number: SK1703.

Distribution pattern: U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.