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Model Number RF-NE-10 |
Device Problem
Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant device: reusable electrode, 10cm, nitinol.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
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Event Description
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Related manufacturing ref: 3004617090-2020-00003.During device testing, the probes started smoking when testing on the grounding pad.There was no patient involved.
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Manufacturer Narrative
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The device was returned due to a "smoking probe" while testing on the grounding pad.The electrode displayed a temperature increase when exposed to heat, however the device did not function as intended during a simulated lesion test.Further investigation revealed, no broken wires were identified and the probe passed dimensional and functional testing.The device was dissected and revealed no anomalies.The device was manufactured according to specifications as supported by the receiving inspection results and all electrodes produced for abbott are confirmed to be conforming to product specifications via in-process controls prior to shipment per 100% continuity and resistance testing at minta.The cause of the temperature issue remains unknown.
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Search Alerts/Recalls
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