Catalog Number 5100015250 |
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 06/30/2023 |
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 6 events were reported for this quarter.Product return status 3 devices were received.3 device investigation types have not yet been determined.Additional information 6 devices were not labeled for single-use.6 devices were not reprocessed or reused.
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Event Description
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This report summarizes 6 malfunction events in which the device had a component detach.- 3 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.
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Event Description
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This report summarizes 6 malfunction events in which the device had a component detach.- 3 events had no patient involvement; no patient impact.- 3 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 6 previously reported events are included in this follow-up record.Product return status 3 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.
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Event Description
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This report summarizes 5 malfunction events in which the device had a component detach.3 events had no patient involvement; no patient impact.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: 6 events were previously reported during the reporting period; however, 1 previously reported event in this report should have been included under mfr report # 3015967359-2023-01617.5 previously reported events are included in this follow-up record.Product return status: 3 devices were received.2 devices were not available for evaluation.
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Search Alerts/Recalls
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