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Recall Observatory FDA recall evidence

Device product

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

Z-1431-2013

May 08, 2013

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 65194
Status
Terminated
Classification
Class II
Quantity
697 units - all products
Official record key
device-enforcement:Z-1431-2013

Official wording

Reason: 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.

Code information: Model number: 400110-10; Lot numbers: M10120807 M10120817 M10120831 M10120910 M10121008 M10121012 M10121024 M10121115 M10121123 M10121130 M10121206 M10121210 M10130124 M10130131 M10130205 M10130304 M10130319 M10130321

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.