Catalog Number 8208000000 |
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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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 12 events were reported for this quarter.Product return status 11 devices were received.1 device investigation type has not yet been determined.Additional information 12 devices were not labeled for single-use.12 devices were not reprocessed or reused.
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Event Description
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This report summarizes 12 malfunction events in which the device had a component detach.- 12 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: h6, h11 12 previously reported events are included in this follow-up record.Product return status 12 devices were received.
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Event Description
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This report summarizes 12 malfunction events in which the device had a component detach.- 12 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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