Model Number 6118097090 |
Device Problems
Delivered as Unsterile Product (1421); No Apparent Adverse Event (3189)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Awaiting device return.
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Event Description
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It was reported that during incoming inspection, the customer noticed foreign material inside the package.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
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Event Description
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It was reported that during incoming inspection, the customer noticed foreign material inside the package.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.It was subsequently confirmed that there was no impact to the sterility of the package following inspection of the returned device.
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Manufacturer Narrative
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B5: following inspection of the returned device, this is not a reportable event.H6: the quality investigation is complete.
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Search Alerts/Recalls
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