Catalog Number 0306330000 |
Device Problem
Fracture (1260)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
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: 2 events were reported for this quarter.Product return status: 2 device investigation types have not yet been determined.Additional information: 2 devices were labeled for single-use.2 devices were not reprocessed or reused.
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Event Description
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This report summarizes 2 malfunction events in which the device or cutting accessory fractured.2 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: 2 events were originally reported for this failure mode during the reporting quarter; however, 5 events were inadvertently excluded.7 reported events are included in this follow-up record.Product return status: 7 device investigation types have not yet been determined.
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Event Description
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This report summarizes 7 malfunction events in which the device or cutting accessory fractured.2 events had patient involvement; no patient impact.5 events had insufficient information received.
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Event Description
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This report summarizes 7 malfunction events in which the device or cutting accessory fractured.- 2 events had patient involvement; no patient impact.- 5 events had insufficient information received.
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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: h10 7 previously reported events are included in this follow-up record.Product return status 6 devices were not available for evaluation.1 device investigation type has not yet been determined.
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Event Description
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This report summarizes 7 malfunction events in which the device or cutting accessory fractured.2 events had patient involvement; no patient impact.5 events had insufficient information received.
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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: h10.7 previously reported events are included in this follow-up record.Product return status: 1 device was received.6 devices were not available for evaluation.
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Search Alerts/Recalls
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