Model Number 2800 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2024 |
Event Type
malfunction
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Event Description
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It was reported that foreign material was observed on the device.Following opening of the package, a black hair was noted on the encore 26 locking button.The device was not used.The procedure was completed with a replacement device and no patient complications were reported.
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Manufacturer Narrative
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The returned product consisted of the encore ic device.The device was returned with its original pouch and overall visual review did not identify failures or evidence that could be lost due to decontamination process.The gauge needle was at 0 atm when received.There was no visual evidence of a black hair on the yellow button of the device.Based on the device investigation, the reported event could not be confirmed.
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Event Description
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It was reported that foreign material was observed on the device.Following opening of the package, a black hair was noted on the encore 26 locking button.The device was not used.The procedure was completed with a replacement device and no patient complications were reported.
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Search Alerts/Recalls
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