Model Number UNKNOWN |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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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 the legal documents.The device used at this facility is not believed to be a system 83 plus device.
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Event Description
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Adverse event as alleged solely in legal documents.See supplemental report.
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Manufacturer Narrative
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Corrections: describe event or problem updated to: it is solely alleged, through legal documents, that the adverse event was death.However, it is believed the device used at this facility was not a system 83 plus device.Investigation is on-going to this extent.Type of reportable event corrected from serious injury to death.
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Event Description
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It is solely alleged, through legal documents, that the adverse event was death.However, it is believed the device used at this facility was not a system 83 plus device.Investigation is on-going to this extent.In addition, all liability is denied.
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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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