Model 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 09/30/2022 |
Event Type
malfunction
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Event Description
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This report summarizes 3 malfunction events in which the device or cutting accessory fractured.2 events had no patient involvement; no patient impact.1 event 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 3 events were reported for this quarter.Product return status 2 devices were not available for evaluation.1 device investigation type has not yet been determined.Additional information 3 devices were not labeled for single-use.3 devices were reprocessed or reused.
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Manufacturer Narrative
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Additional information: 3 device was not reprocessed or reused.
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Event Description
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This report summarizes 3 malfunction events in which the device or cutting accessory fractured.2 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Event Description
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This report summarizes 3 malfunction events in which the device or cutting accessory fractured.- 2 events had no patient involvement; no patient impact.- 1 event 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,h10 3 previously reported events are included in this follow-up record.Product return status 3 devices were not available for evaluation.
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Search Alerts/Recalls
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