Catalog Number 5500255000 |
Device Problem
Inability to Irrigate (1337)
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Patient Problem
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 6 events were reported for this quarter.Product return status 4 devices were received.2 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 experienced an irrigation issue that could lead to overheating.- 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 experienced an irrigation issue that could lead to overheating.- 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, h11 6 previously reported events are included in this follow-up record.Product return status 5 devices were received.1 device investigation type has not yet been determined.
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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 6 previously reported events are included in this follow-up record.Product return status 6 devices were received.
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Event Description
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This report summarizes 6 malfunction events in which the device experienced an irrigation issue that could lead to overheating.- 4 events had no patient involvement; no patient impact.- 2 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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