Catalog Number 4343 |
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 on the blade are broken within the package.
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Manufacturer Narrative
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(b)(4).Lot# has been corrected to 1604332.A device history record (dhr) review was performed on the batch number 1604332 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 on the blade are broken within the package.
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Search Alerts/Recalls
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