da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Reported: July 12, 2023 Initiated: June 12, 2023 #Z-2059-2023
Product Description
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 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.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12. Recalled by Intuitive Surgical, Inc.. Units affected: 46,033.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2059-2023.
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