Catalog Number 4319 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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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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(b)(4) the results of the investigation are incomplete at the time of this report.
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Event Description
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The customer alleges that the plastic parts of the blade are already broken inside the package.
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Manufacturer Narrative
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(b)(4).A device history record (dhr) review was performed on the batch number (b)(4) and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.Based on the investigation performed, the complaint was confirmed.A capa has been opened to further investigate this issue.
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Event Description
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The customer alleges that the plastic parts of the blade are already broken inside the package.
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Search Alerts/Recalls
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