Catalog Number 4100062000 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Patient Involvement (2645)
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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).1 device is available for evaluation but has not yet been received.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 was reportedly shedding metal debris.There was no patient involvement; no patient impact.
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, (b)(4).One device was received for evaluation.One event was confirmed during evaluation.A component was found to be shedding metal debris.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 was reportedly shedding metal debris.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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