—#71855

Product

da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050369, K060322
Affected lot / code info: Serial numbers SG099, SG145, SG162, SG205, SG294, SG295, SG298, SG299, SG300, SG301, SG302, SG303, SG304, SG305, SG306, SG307, SG308, SG309, SG310, SG311, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG320, SG321, SG322, SG323, SG324, SG325, SG326, SG327, SG328, SG329, SG330, SG331, SG332, SG333, SG334, SG35, SG336, SG337, SG39, SG340, SG341, SG342, SG323, SG344, SG345, SG346, SG347, SG348, SG349, SG350, SG351, SG352, SG353, SG355, SG356, SG357, SG358, SG359, SG360, SG361, SG362, SG363, SG364, SG365, SG367, SG368, SG369, SG370, SG371, SG373, SG374, SG375, SG376, SG379, SG380, SG381, SG382, SG383, SG384, SG385, SG386, SG387, SG388, SG390, SG393, SG394, SG395, SG396, SG397, SG399, SG400, SG401, SG402, SG403, SG404, SG405, SG406, SG407, SG408, SG409, SG410, SG411, SG412, and SG413

Why it was recalled

Defective software chip may cause the system to fail and lock up.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Recall initiated June 1, 2008. Urgent Device Recall Letters were sent via e-mail, with follow up phone calls and service visits to correct the product. The firm recommended that continued use of the da Vinci S Surgical System during the time period prior to our service update to replace the software chip. The letter emphasizes the importance of always having backup equipment and instrumentation available when performing surgery with the da Vinci S Surgical System and being prepared to convert to alternative surgical techniques, if necessary. Customers are asked to fill out and return the acknowledgement form.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Belgium, Bulgaria, Canada, China, Denmark, France, Germany, Italy, Korea, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, and United Kingdom.

Timeline

Recall initiated: 2008-06-01
Posted by FDA: 2008-09-16
Terminated: 2009-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71855. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.