PlainRecalls
FDA Devices Moderate Class II Terminated

8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

Reported: June 5, 2013 Initiated: May 8, 2013 #Z-1432-2013

Product Description

8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

Reason for Recall

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.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
697 - all products
Distribution
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.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.. Recalled by Intuitive Surgical, Inc.. Units affected: 697 - all products.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1432-2013.