Catalog Number 0408721000 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2020 |
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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.1 device was labeled for single-use.1 device was 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 material that was split, cut, or torn due to external or internal forces.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 corrected data: b5, b6, h10 1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.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 material that was split, cut, or torn due to external or internal forces.1 event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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