Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Da Vinci S 8mm Instrument Cannula

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Da Vinci S 8mm Instrument Cannulasee related information
Date Initiated by FirmJanuary 04, 2008
Date PostedAugust 06, 2008
Recall Status1 Terminated 3 on March 31, 2011
Recall NumberZ-1348-2008
Recall Event ID 46890
Product Classification Computer Controlled Instrument - Product Code NAY
ProductDa Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments. Product is distributed by Intuitive Surgical, Inc., Sunnyvale, CA
Code Information Lot Numbers: 13730-01-70807, 13793-71106, 13730-02-70807, WI073202, WI074501, WI073201  
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale CA 94086-5206
For Additional Information ContactMike Yramategui
408-523-2100
Manufacturer Reason
for Recall		(1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function. (2) Incorrect labeling. External labeling lot number differs from lot number etched on the cannula.
FDA Determined
Cause 2		Process control
ActionOn 1/4/08, the firm initiated the recall and its notification was via Urgent Device Recall letters explaining the reason for the recall, requesting immediate discontinued use, segregate non-conforming product in a secure area, and a Customer Service Rep will make contact in order to arrange for the retrieval of the material.
Quantity in Commerce39 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-