Model Number 5407-120-950C |
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 06/30/2022 |
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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
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Event Description
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This report summarizes 1 malfunction event in which the device had a component detach.1 event 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: 1 event was previously reported during the reporting quarter; however, - 1 event was reported in error.- 0 previously reported events are included in this follow-up record.H3 other text : there are no events to report for this catalog#/failure.
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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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