Catalog Number P2000 |
Device Problems
Off-Label Use (1494); Pressure Problem (3012)
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Patient Problem
Hyponatremia (4494)
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Event Date 05/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the patient experienced turp syndrome symptoms and was admitted to the icu.
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Manufacturer Narrative
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Updating to reference correct fda registration number - 3007495879 - endoscopy (solon).
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Event Description
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It was reported that the patient experienced turp syndrome symptoms and was admitted to the icu.
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Manufacturer Narrative
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Reference correct fda registration number: (b)(4) endoscopy (solon).This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: patient was experiencing turp syndrome symptoms.Probable root cause: user error, selection of incorrect procedure and pressure above safe limits for procedure leading to fluid intravasation the reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the patient experienced turp syndrome symptoms and was admitted to the icu.
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Search Alerts/Recalls
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