Model Number 27040G |
Device Problem
Break (1069)
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Patient Problem
Perforation (2001)
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Event Date 01/21/2024 |
Event Type
Injury
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Manufacturer Narrative
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The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
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Event Description
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It was reported that the item broke during the procedure and remained inside the urethra.The rest of the electrode remained inside the urethra.During the removal of the broken off part from the urethra, the urethra was damaged, which required the patient to be hospitalized for two more days.
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Manufacturer Narrative
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Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
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Manufacturer Narrative
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Result of investigation: based on the results of the investigation, it is assumed that the user is at fault.The pictures show that the sling wire is severely bent and pulled out of the sling linkage.This is due to excessive force.A possible cause of this could be, for example, that the snare was used without activated hf current, so that the cutting function was not given.The event is filed under internal karl storz complaint id: (b)(4).
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Search Alerts/Recalls
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