Harmonic Ace Instructions For Use

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while adhering to the instructions for use, or. 6. The Harmonic ACE®+7 Shears will be assembled, calibrated,



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Page 1 of 13 Reprocessed by Instructions for Use Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology Reprocessed Device for Single Use

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Model Number ACE 14S: Event Date 03/23/2011: Event Type Malfunction Event Description Surgeon was using the harmonic ace 14s curved shears with scissor handles when the blade from the shear broke in half. There was nothing unusual with anatomy or use of the product. Diagnosis or reason for use: thyroidectomy.

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For complete product details, see Instructions for Use (available at www.e-ifu.com). HARMONIC ACE®+ 7 is significantly more consistent in

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The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled, calibrated, and/or used in accordance with manufacturer design specifications, product instructions and guidelines

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Early versions of the 5 mm ultrasonic shears were limited to sealing vessels up to 3 mm by the instructions for use with Harmonic ACE at power

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Field Safety Notice Urgent Medical Device Correction the Harmonic ACE Curved Shears Instructions for Use Urgent Medical Device Correction – 2955842-12-22

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