Model Number N/A |
Device Problem
Device Reprocessing Problem (1091)
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Patient Problem
No Information (3190)
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Event Date 02/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-01662 / 01663).Device requested, not yet received.
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Event Description
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Depth gauge cannot be cleaned properly due to a glue residue that cannot be washed off.There was no delay or patient injury.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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