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Model Number N/A |
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 12/15/2023 |
Event Type
malfunction
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Event Description
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As reported, prior to use for an unknown procedure, an ngage nitinol stone extractor's distal end of basket wires detached from the basket sheath.The observation was made prior to patient contact.The patient did not require any additional procedures or experience any adverse effects 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.E1- (b)(6).G4- pma/510(k) #: exempt.H3 - device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 or that a death or serious injury occurred; nor is it admission 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 unchanged, 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 12mar2024: another device of the same type was used to complete the procedure.
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Search Alerts/Recalls
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