Catalog Number 0400850000 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/30/2019 |
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: 4 events were reported for this quarter.Product return status: 4 device investigation types have not yet been determined.Additional information: 4 devices were labeled for single-use.4 devices were not reprocessed or reused.
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Event Description
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This report summarizes 4 malfunction events in which the device had material that was split, cut, or torn due to external or internal forces.4 events had patient involvement; no patient impact.
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Event Description
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This report summarizes 4 malfunction events in which the device had material that was split, cut, or torn due to external or internal forces.4 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 corrected data: h10 4 previously reported events are included in this follow-up record.Product return status 4 devices were not available for evaluation.H3 other text : device not returned.
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Search Alerts/Recalls
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