Catalog Number 0277096326 |
Device Problem
Fracture (1260)
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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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Event Description
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This report summarizes 7 malfunction events in which the device or cutting accessory fractured.7 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.Reported events 7 events were reported for this quarter.Product return status 4 devices were evaluated based on historical data analysis.3 device investigation types have not yet been determined.Additional information 7 devices were labeled for single-use.7 devices were not reprocessed or reused.
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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: 7 previously reported events are included in this follow-up record.Product return status: 2 devices were received.5 devices were evaluated based on historical data analysis.
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Event Description
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This report summarizes 7 malfunction events in which the device or cutting accessory fractured.7 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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