Catalog Number 0408800000 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 2 malfunction events in which the device had debris in sterile package.- 2 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.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 1 malfunction event in which the device had debris in sterile package.1 event 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: 2 events were previously reported during the reporting quarter; however, 1 event was reported in error.1 previously reported event is included in this follow-up record.Product return status: 1 device investigation type has not yet been determined.
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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: b5, h6, h10 2 events were previously reported during the reporting period; however, - 1 previously reported event in this report should have been included under mfr report # 3015967359-2023-02260.- 1 previously reported event is included in this follow-up record.Product return status 1 device was received.H3 other text : device discarded.
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Event Description
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This report summarizes 1 malfunction event in which the device had debris in sterile package.- 1 event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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