—#50550

Product

8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, 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: K012833
Affected lot / code info: The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected: 0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.

Why it was recalled

The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.

Root cause (FDA determination)

Other

Action the firm took

The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.

Recalling firm

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

Distribution

Distribution pattern: Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.

Timeline

Recall initiated: 2005-03-24
Posted by FDA: 2007-03-28
Terminated: 2007-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50550. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.