COOPER SURGICAL, INC. ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM; TUBE, SMOKE REMOVAL, ENDOSCOPIC
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Model Number 0620-030-606 |
Device Problems
Material Discolored (1170); Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/10/2020 |
Event Type
malfunction
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Event Description
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Product labeling on the cooper surgical, ultra plume-away 6.0, smoke evacuation system had been noted to be discolored (yellowish color to portion of label) upon its arrival.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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