Model Number UNKNOWN |
Device Problem
Insufficient Information (3190)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 12/01/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Currently it is denied that the system 83 plus device may have caused or contributed to the adverse event as alleged in lawsuit.
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Event Description
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Adverse event as alleged solely in a lawsuit.
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Manufacturer Narrative
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This matter and any investigation related to the same is officially closed.The complaint only arose solely out of allegations in lawsuit and this lawsuit has been resolved with absolutely no finding of liability or wrong doing on behalf of custom ultrasonics, inc.
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Manufacturer Narrative
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With respect to this reported adverse event, there has been absolutely no finding of wrongdoing on the part of custom ultrasonics, inc.In addition, there has been absolutely no finding of any related functionality issues with the system 83 plus 2 and plus 9 automated endoscope reprocessor ("aer") and the aer's ability properly reprocess endoscopes.
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Search Alerts/Recalls
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