—#166162

Product

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

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K131861
Affected lot / code info: UDI Number: 00886874114193. Serial Number: SK1703.

Why it was recalled

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.

Root cause (FDA determination)

Use error

Action the firm took

Intuitive Surgical notified customers via a "Field Safety Notice Urgent Medical Device Correction ISIFA2018-06-C da Vinci Xi Miscalibrated Endoscope Controller" letter. The letter provided: Reason for Field Action, Risk to Health, Affected Products (description, part number, serial number), Action taken by Intuitive Surgical, Actions to be taken by the Customer/ User, contact information for Further Information & Support, and an Acknowledgement Form.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: U.S.

Timeline

Recall initiated: 2018-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166162. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.