Catalog Number 244000544 |
Device Problem
Device Disinfection Or Sterilization Issue (2909)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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A new kit of pinnacle instruments was sterilized in an autoclave sterilization pouch, at the end of that sterilization process, the pouch was all stained with orange.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
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Search Alerts/Recalls
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