Model Number 00884450458587 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/24/2023 |
Event Type
malfunction
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Event Description
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The account alleges that during the number insertion, the nephroureteral stent system came out completely instead of just 2 centimeters.The physician had to cut the catheter to dislodge the stent.No patient harm.
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number have been identified.Should the device be returned at a later date, the investigation will be reopened.
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Search Alerts/Recalls
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