Catalog Number 7203126000 |
Device Problem
Biocompatibility (2886)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/02/2017 |
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).One (1) event was reported for this quarter.One (1) device was 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 one (1) malfunction event in which the device was reportedly received with a contaminant on the device.One (1) reported event had 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 e2015055.Supplemental rationale.1 previously reported event is 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.Device not received for evaluation.
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Event Description
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This report summarizes 1 malfunction event in which the device was reportedly received with a contaminant on the device.1 reported event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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