Catalog Number 5407120450 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); 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.5 events were reported for this quarter.Product return status.4 devices were received.1 device investigation type has not yet been determined.Additional information.5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
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Event Description
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This report summarizes 5 malfunction events in which the device had a component detach.2 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.1 event had insufficient information 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 5 previously reported events are included in this follow-up record.Product return status 5 devices were received.
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Event Description
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This report summarizes 5 malfunction events in which the device had a component detach.- 2 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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