Model Number 8203126000 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
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: 29 events were reported for this quarter.Product return status: 28 devices were evaluated in the field.1 device investigation type has not yet been determined.Additional information: 29 devices were not labeled for single-use.29 devices were not reprocessed or reused.
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Event Description
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This report summarizes 29 malfunction events in which the device had paint chips missing.29 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: h10.29 previously reported events are included in this follow-up record.Product return status : 29 devices were evaluated in the field.
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Event Description
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This report summarizes 29 malfunction events in which the device had paint chips missing.- 29 events had no patient involvement; no patient impact.
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Event Description
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This report summarizes 29 malfunction events in which the device had paint chips missing.29 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: h10: 29 previously reported events are included in this follow-up record.Product return status: 1 device was received.28 devices were evaluated in the field.
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Search Alerts/Recalls
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