Catalog Number 5407120470 |
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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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 74 events were reported for this quarter.Product return status 74 devices were evaluated in the field.Additional information 74 devices were not labeled for single-use.74 devices were not reprocessed or reused.
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Event Description
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This report summarizes 74 malfunction events in which the device had paint chips missing.- 74 events had no patient involvement; no patient impact.
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Event Description
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This report summarizes 76 malfunction events in which the device had paint chips missing.- 76 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 corrected data: b5, h6, h10 74 events were originally reported for this failure mode during the reporting quarter; however, - 2 events were inadvertently excluded.- 76 reported events are included in this follow-up record.Product return status 76 devices were evaluated in the field.Additional information 76 devices were not labeled for single-use.76 devices were not reprocessed or reused.
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Search Alerts/Recalls
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