Catalog Number 4208000000 |
Device Problems
Leak/Splash (1354); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/03/2015 |
Event Type
malfunction
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Event Description
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It was reported that the device is not working properly during a procedure at user facility.There was a delay of unknown length.Additional information has been requested from the user facility.It was found during service inspection that there is water inside the handpiece.
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Manufacturer Narrative
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The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
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Manufacturer Narrative
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Device was repaired and returned to the customer after passing the final inspection.
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Event Description
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It was reported that the device is not working properly during a procedure at user facility.There was a delay of unknown length.Additional information has been requested from the user facility.It was found during service inspection that there is water inside the handpiece.
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Search Alerts/Recalls
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