—#70822

Product

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070947
Affected lot / code info: Lot Number: 802011

Why it was recalled

The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.

Root cause (FDA determination)

Software design

Action the firm took

On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100.

Recalling firm

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

Distribution

Distribution pattern: Class II Recall - Nationwide Distribution --- including states of NC, OH, GA and WI.

Timeline

Recall initiated: 2008-04-18
Posted by FDA: 2008-09-17
Terminated: 2011-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.