Catalog Number 4100125000 |
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).1 device was returned for evaluation.1 event was confirmed during testing.The device was found to be affected by a ball retainer assembly.4 devices are available for evaluation but have not yet been evaluated.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 5 malfunction events in which the device produced metal shavings.1 event had patient involvement with no patient impact.3 reported events had no patient involvement; no patient impact.1 reported event had no information available from the facility regarding patient involvement or 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).Four devices were received for evaluation; 3 events were confirmed during testing.Three devices were found to be affected by metal shavings.One device found to be within specifications for the reported event.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 5 malfunction events in which the device produced metal shavings.One event had patient involvement with no patient impact.Three reported events had no patient involvement; no patient impact.One reported event had no information available from the facility regarding patient involvement or patient impact.
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Search Alerts/Recalls
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