—#179714

Product

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.

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: IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137

Why it was 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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Send formal customer letter communication to the affected site. The firm reported that a representative scheduled an on-site visit to replace the affected unit.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution including in the state of Washington.

Timeline

Recall initiated: 2019-06-17
Terminated: 2022-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.