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Catalog Number BLACKMAX-N |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/21/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during pre-testing process, it was observed that the handpiece device lost pressure and would not turn.There were no delays in the surgical procedure as an identical spare device was available for use.There was no patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that oil leaked from shift lever and the hose had a hole that was visibly hard to detect.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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