Model Number 756508025 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/25/2022 |
Event Type
malfunction
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Event Description
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When doing left and right intrahepatic bile duct drainage for a patient, the drainage tube is not well sealed at the exit of the pull wire outside the body, causing gas to enter the human body from it, and body fluid to leak out from the thread opening, which cannot be used.The same problem occurs.
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.It was not necessary to check any other documentation in the course of investigating this complaint.According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.
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Event Description
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When doing left and right intrahepatic bile duct drainage for a patient, the drainage tube is not well sealed at the exit of the pull wire outside the body, causing gas to enter the human body from it, and body fluid to leak out from the thread opening, which cannot be used.The same problem occurs.
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Search Alerts/Recalls
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