Catalog Number 5100007000 |
Device Problem
Device Remains Activated (1525)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/02/2017 |
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).2 events were reported for this quarter.1 devices were received for evaluation.1 device was available for evaluation but has not yet been received. 1 event was confirmed during testing.1 device was found to be affected by a deformed boot.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 2 malfunction events in which the device had run-on.1 event had no patient involvement; no patient impact.1 event had 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 e2015055. supplemental rationale corrected data: 1 previously reported events are included in this follow-up record. product return status 1 device was not available to stryker for evaluation. additional information 1 device is not labeled for single-use.1 device was not reprocessed and reused.H3 other text : device not returned.
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Event Description
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This report summarizes 2 malfunction events in which the device had run-on.1 event had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Search Alerts/Recalls
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