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U.S. Department of Health and Human Services

Class 2 Device Recall 8MM TIPUP FENESTRATED GRASPER, IS4000

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  Class 2 Device Recall 8MM TIPUP FENESTRATED GRASPER, IS4000 see related information
Date Initiated by Firm June 12, 2023
Date Posted June 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-2059-2023
Recall Event ID 92418
510(K)Number K131861  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Code Information UDI-DI: 00886874112496, All Lots.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		 Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
FDA Determined
Cause 2		 Process control
Action On 6/12/23 Field Safety Notices were mailed and emailed to customers asking them to do the following: 1) Locate and return affected devices. 2) Notify all surgeons and users of the device about the contents of the notice. 3) Complete and return the acknowledgement form to Recalls@intusurg.com If you need further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Customer Service at: - North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) - India: +1-800-103-6952 (9 AM to 6 PM IT) - Taiwan: +0800-86-8181 (9 AM to 6 PM CT)
Quantity in Commerce 46,033
Distribution Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY, AL, MO, LA, DE, MA, MT, WV, ID, CT, NV, NH, ME, WY, DC, RI, NM, VT and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Monaco, Netherlands, Norway, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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