da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- June 12, 2023
- Posted
- June 30, 2023
- Recall Number
- Z-2059-2023
- Quantity
- 46,033
- Firm Location
- Sunnyvale, CA
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.
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.
Lot / Code Info
UDI-DI: 00886874112496, All Lots.
Root Cause
Process control
Action Taken
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)