Catalog Number 0306330000 |
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 09/30/2022 |
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.1 event had no patient involvement; no patient impact.1 event 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: 1 device was evaluated in the field.1 device was not available for evaluation.Additional information: 2 devices were labeled for single-use.2 devices were reprocessed or reused.Device not available.
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Event Description
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This report summarizes: 2 malfunction event.S in which, the device had a component detach.1 event, had no patient involvement.No patient impact.1 event, had patient involvement.No patient impact.
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Manufacturer Narrative
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Additional information: 2 devices were not reprocessed or reused.
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Search Alerts/Recalls
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