Catalog Number 5100088000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/11/2013 |
Event Type
malfunction
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Event Description
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The tps micro driver was returned to stryker instruments for service, and during product evaluation it was noted that potting was leaking out of the handpiece.There was no patient involvement and no adverse consequences associated with the device.
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Manufacturer Narrative
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The engineering technician confirmed the reported event of leaking, and noted that an uncured potting solution had seeped out from the boot.The root cause was determined to be of out-of-specification potting solution received from the supplier.
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Event Description
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The tps micro driver was returned to stryker instruments for service, and during product evaluation it was noted that potting was leaking out of the handpiece.There was no patient involvement and no adverse consequences associated with the device.
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Manufacturer Narrative
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Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.
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Search Alerts/Recalls
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