Catalog Number 5100015250 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/25/2018 |
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 received.Evaluation status : in progress, 2 device evaluations are in progress.Additional information : 2 devices were not labeled for single-use, 2 devices were not reprocessed and reused.
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Event Description
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This report summarizes 2 malfunction events in which the device had a broken cutting accessory still attached, 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 corrected data: 2 previously reported events are included in this follow-up record. product return status 2 devices were received.Event confirmation status 2 reported events were confirmed; the cause traced to component failure.Evaluation results 2 devices were found to be affected by internal component damage.
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Event Description
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This report summarizes 2 malfunction events in which the device had a broken cutting accessory still attached.2 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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