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Model Number N/A |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/15/2024 |
Event Type
malfunction
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Event Description
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It was reported the ngage nitinol stone extractor could not be opened during an unspecified procedure.Additional information has been requested but is unavailable at this time.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = line 2: (b)(6).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 unchanged, unknown, or unavailable.Additional information: d4, d9 and h4 h3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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