Catalog Number 0504990800 |
Device Problems
Corroded (1131); Device Packaging Compromised (2916); Knife (3156)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/23/2018 |
Event Type
Malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.
However, should it become available it will be provided in future reports.
Additional information will be provided once the investigation has been completed.
(b)(4).
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Event Description
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It was reported that the sterile packaging may have been contaminated; causing the knife to be rusted.
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Manufacturer Narrative
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Alleged failure: the end of the knife is rusted the failure(s) identified in the investigation is consistent with the complaint record.
The probable root cause could be manufacturing process sterility.
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
The device manufacturer date is not known.
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Event Description
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It was reported that the sterile packaging may have been contaminated; causing the knife to be rusted.
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Search Alerts/Recalls
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