Catalog Number 00-5150-482-01 |
Device Problems
Leak/Splash (1354); Overheating of Device (1437); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2015 |
Event Type
malfunction
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Event Description
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It was reported that the battery pack of the hip kit produced heat during surgery and the batteries leaked.Only the battery pack part was returned from the customer.The surgery was finished with an alternative device.There was no report of pt or user harm or surgical delay associated with the report.No add'l clinical info was rec'd prior to this report.
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Manufacturer Narrative
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The device was returned to the mfr; however the investigation was not completed at the time of this report.A f/u medwatch will be submitted once the investigation is complete.
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Search Alerts/Recalls
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