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Model Number 2067L |
Device Problem
Cut In Material (2454)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/23/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: manufacturer's analysis indicated that the insulation of the cable of the radiofrequency head was cut but functional, and that the label was delaminated.The cable and label were replaced and the head passed all functional and systems tests.(b)(4).
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Event Description
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The radiofrequency (rf) head, which was returned as an associated device, also tested out of specification during manufacturer's analysis.There was no patient involvement.
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Search Alerts/Recalls
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