Catalog Number 4100126000 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One device is available for evaluation but has not yet been evaluated.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 1 malfunction event in which the device produced metal shavings.There was patient involvement with no patient impact.
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Manufacturer Narrative
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(b)(4).One device was received for evaluation; the event was confirmed during testing.The device was found to be affected by metal shavings.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 1 malfunction event in which the device produced metal shavings.There was patient involvement with no patient impact.
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Search Alerts/Recalls
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