—#50544

Product

Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369
Affected lot / code info: System Numbers: SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.

Why it was recalled

Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.

Root cause (FDA determination)

Other

Action the firm took

The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 950 Kifer Rd, Sunnyvale, California 94086-5206

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-04-12
Posted by FDA: 2007-03-29
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.