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Catalog Number NGE-017115-MB |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Event Description
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As reported, during the stone removal procedure from the right kidney, the ngage nitinol stone extractor broke in the process.A photo of the device shows the detachment of the basket wire from the basket sheath.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E3: customer occupation = urology clinician g4: pma/510(k) number = exempt this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Additional information received on 01feb2024.The procedure was completed with a new basket.
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Search Alerts/Recalls
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