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Recall Observatory FDA recall evidence

Device product

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

Z-1432-2013

May 08, 2013

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 65194
Status
Terminated
Classification
Class II
Quantity
697 - all products
Official record key
device-enforcement:Z-1432-2013

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: 400172-08; Lot numbers: M10120815 M10120817 M10120831 M10120913 M10120918 M10121008 M10121024 M10121120 M10121123 M10121203 M10121210 M10121215 M10130220 M10130222 M10130311 M10130315 M10130327 M10130411.

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.