PlainRecalls
FDA Devices Moderate Class II Terminated

da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.

Reported: November 4, 2020 Initiated: June 17, 2019 #Z-0283-2021

Product Description

da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.

Reason for Recall

One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
1 system
Distribution
US Nationwide distribution including in the state of Washington.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled? ▼
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.. Recalled by Intuitive Surgical, Inc.. Units affected: 1 system.
Why was this product recalled? ▼
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0283-2021.

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