Catalog Number 5100015250 |
Device Problem
Fracture (1260)
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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.4 events were reported for this quarter.Product return status.3 devices were received.1 device investigation type has not yet been determined.Additional information.4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
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Event Description
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This report summarizes 4 malfunction events in which the device or cutting accessory fractured.4 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, h10 4 previously reported events are included in this follow-up record.Product return status 3 devices were received.1 device was not available for evaluation.
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Event Description
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This report summarizes 4 malfunction events in which the device or cutting accessory fractured.4 events had no patient involvement; no patient impact.
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Search Alerts/Recalls
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