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Intuitive Surgical, Inc. recalls 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrument
Recalled December 3, 2014 · FDA recall Z-0447-2015 · Intuitive Surgical
Hazard
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. · FDA Class II
Units
509 total units, all affected devices
Sold at
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
Description
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Product
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →