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Catalog Number 72200616S |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during an unknown procedure that the hand piece was overheating.
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Manufacturer Narrative
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Evaluation narrative - the subject device, one service replacement powermax elite, part number 72200616s was received on december 16th, 2015 and confirmed to be serial number (b)(4).Functional testing has found that the motor has seized, no additional test is possible with a seized motor.Unit was disassembled and inspected; corrosion was not found which would indicate a mechanical failure of the motor gearbox.The root cause of the overheated condition is most likely associated with the seized motor.A review of the device service records indicate that this serial number was delivered to the complainant in january of 2014.The complaint investigation has concluded that this unit has succumbed to expected wear and tear.(b)(4).
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Search Alerts/Recalls
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