Catalog Number 5400007000 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2016 |
Event Type
malfunction
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Event Description
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The user facility reported seeing exposed wires during setup prior to a procedure.The user facility reported that there were no surgical delay or adverse consequences related to this event.
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Manufacturer Narrative
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Added information from the investigation.
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Event Description
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The user facility reported seeing exposed wires during setup prior to a procedure.The user facility reported that there were no surgical delay or adverse consequences related to this event.
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Manufacturer Narrative
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Manufacturer report number 0001811755-2016-02840 was filed in error. additional information regarding the event clarified that the customer did not experience a reportable event per 21 cfr 803:20.
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Event Description
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The user facility reported seeing exposed wires during setup prior to a procedure.The user facility reported that there were no surgical delay or adverse consequences related to this event.
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Search Alerts/Recalls
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