Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road, Sunnyvale, CA
FDA Recall Z-0669-2008 · Posted 2008-01-31
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2007-11-19
Date Terminated2008-08-27
Product Quantity89 units
Reason for Recall
Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.
Firm Action
On 11/19/07, the firm issued Urgent Device Recall Notification letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Root Cause
Other
Distribution Pattern
Worldwide: USA including states of AZ, CA, CT, DC, GA, lA, MI, MN, NC, NJ, NV, OH, PA, SD, TX, and VA and country of Hong Kong
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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