Model Number TCN-10 |
Device Problems
Material Discolored (1170); Material Erosion (1214)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Expiration date: na.
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Event Description
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Device analysis performed on the electrode showed that the epoxy has a red deposit, a chip out and brown-red discoloration was noted.
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Manufacturer Narrative
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Additional information was received that the color of a newly cured epoxy is amber or light brown.If the epoxy is subjected to too many autoclave cycles, it becomes brittle and discolored.
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Event Description
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Device analysis performed on the electrode showed that the epoxy has a red deposit, a chip out and brown-red discoloration was noted.
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Search Alerts/Recalls
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