Catalog Number 5407FA2000 |
Device Problem
Bent (1059)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/02/2017 |
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).13 devices were received for evaluation; 12 events were confirmed during testing.12 devices were found to be bent.1 device evaluation is in progress.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 13 malfunction events in which the device was bent.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, exemption number (b)(4).There were no remedial actions taken.This device is not labeled for single-use.Correction: one device was expected for evaluation; however, the device was not available.Product not available.
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Event Description
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This report summarizes 13 malfunction events in which the device was bent.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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