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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Recall Number Z-1433-2013
Classification Class II
Code Info 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.
Product Distributed Qty 697 - all products
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.

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.