Catalog Number 5407NFA8CM |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 15 malfunction events in which the device had paint chips missing.- 15 events had no patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 15 events were reported for this quarter.Product return status 15 devices were evaluated in the field.Additional information 15 devices were not labeled for single-use.15 devices were not reprocessed or reused.
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Event Description
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This report summarizes 16 malfunction events in which the device had paint chips missing.16 events had no patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 15 events were originally reported for this failure mode during the reporting quarter; however, 1 events were inadvertently excluded.16 reported events are included in this follow-up record.Product return status: 16 devices were evaluated in the field.Additional information: 16 devices were not labeled for single-use.16 devices were not reprocessed or reused.
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Search Alerts/Recalls
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