Model Number 4100062000 |
Device Problem
Material Disintegration (1177)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/04/2020 |
Event Type
malfunction
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Event Description
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The user facility reported the device emitted metal shavings after a procedure.Emission of metal shavings may cause or contribute to contamination of the surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
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Manufacturer Narrative
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Correction: d10, h3.Additional info h6 h3 other text : device not able to be located.
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Event Description
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The user facility reported the device emitted metal shavings after a procedure.Emission of metal shavings may cause or contribute to contamination of
the surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
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Search Alerts/Recalls
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