Model Number 001-700-001MI |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/08/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint number: (b)(4).The device was received and sent to atricure engineering for analysis.The complaint was confirmed, the magnet cap had failed at the front face resulting in the magnet pulling from the distal end of the probe.
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Event Description
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It was reported that the magnet in the end of the fusion 150 device became dislodged and attached itself to the end of the magnetic introducer.The case was completed with the same device, patients outcome was not affected.
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Search Alerts/Recalls
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