Catalog Number 7126120000 |
Device Problems
Fracture (1260); Difficult to Open or Close (2921)
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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: two events were reported for this quarter.Product return status: two device investigation types have not yet been determined.Additional information: two devices were not labeled for single-use.Two devices were not reprocessed and reused.
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Event Description
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This report summarizes two malfunction events in which the device fractured and difficult to open or close.Two events had patient involvement; no patient impact.
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Event Description
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This report summarizes 2 malfunction events in which the device fractured and difficult to open or close.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 not available for evaluation.
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Search Alerts/Recalls
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