Catalog Number 6203210000 |
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 09/30/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 2 malfunction events in which the device had a component detach.2 events had 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.2 events were reported for this quarter.Product return status.2 device investigation types have not yet been determined.Additional information.2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
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Event Description
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This report summarizes 2 malfunction events in which the device had a component detach.- 2 events had 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: h6, h10 2 previously reported events are included in this follow-up record.Product return status 2 devices were received.
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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, h11 2 events were previously reported during the reporting period; however, - 2 previously reported events in this report should have been included under mfr report # 3015967359-2023-02258.- 0 previously reported events are included in this follow-up record.H3 other text : see h11.
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Event Description
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This report summarizes 0 malfunction events in which the device had a component detach.
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Search Alerts/Recalls
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