Catalog Number 6007-008-000 |
Device Problem
Disassembly (1168)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/08/2016 |
Event Type
malfunction
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Event Description
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It was reported that during testing conducted at the user facility, a button was found to be missing from the device.It was reported that no patient involvement or procedural delays are associated with this event.
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Manufacturer Narrative
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The reported event that there was no button on the device was confirmed through the device inspection.It was observed that the screw at the select button was broken off and the select button was missing.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.
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Event Description
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It was reported that testing conducted at the user facility a button was found to be missing from the device.It was reported that no patient involvement or procedural delays are associated with this event.
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Search Alerts/Recalls
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