Catalog Number 0408800000 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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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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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 devices were not available for evaluation.Additional information 2 devices were labeled for single-use.2 devices were reprocessed or reused.H3 other text : device not available.
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Event Description
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This report summarizes 2 malfunction events in which the device was contaminated with a chemical or other material.- 2 events had patient involvement; no patient impact.
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Manufacturer Narrative
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Additional information: 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 was contaminated with a chemical or other material.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 previously reported during the reporting quarter; however, 2 events were reported in error.0 previously reported events are included in this follow-up record.H3 other text : there are no events to report for this catalog #/failure.
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Event Description
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This report summarizes 0 malfunction events in which the device was contaminated with a chemical or other material.
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Search Alerts/Recalls
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