FDAFDA · Food and drugs·Recall number Z-1433-2013
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Published June 5, 2013 · Recall initiated: May 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
- Lot
- Model number: 400205-04; Lot numbers: M10120816 M10120820 M10120903 M10120910 M10120912 M10120921 M10121008 M10121024 M10121120 M10121130 M10121206 M10121213 M10121215 M10130124 M10130131 M10130213 M10130218 M10130222 M10130313 M10130319 M10130402.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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