Catalog Number 5100015250 |
Device Problem
Unintended Ejection (1234)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
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 3 events were reported for this quarter.Product return status 2 devices were received.1 device investigation type has not yet been determined.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed or reused.
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Event Description
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This report summarizes 3 malfunction events in which the device reportedly unintentionally ejected the cutting device.- 3 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: 3 events were previously reported during the reporting quarter; however, 1 event was reported in error.2 previously reported events are included in this follow-up record.Product return status: 2 devices were received.
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Event Description
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This report summarizes 2 malfunction events in which the device reportedly unintentionally ejected the cutting device.2 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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