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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65194
Product Type Devices
Status Ongoing
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-08
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. 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. Class II 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. 697 - all products Z-1433-2013
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. Model number: 400172-08; Lot numbers: M10120815 M10120817 M10120831 M10120913 M10120918 M10121008 M10121024 M10121120 M10121123 M10121203 M10121210 M10121215 M10130220 M10130222 M10130311 M10130315 M10130327 M10130411. Class II 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. 697 - all products Z-1432-2013
8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments. Model number: 400110-10; Lot numbers: M10120807 M10120817 M10120831 M10120910 M10121008 M10121012 M10121024 M10121115 M10121123 M10121130 M10121206 M10121210 M10130124 M10130131 M10130205 M10130304 M10130319 M10130321 Class II 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. 697 units - all products Z-1431-2013
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