Model Number 7126-120-000 |
Device Problem
Difficult to Open or Close (2921)
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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: 7 events were reported for this quarter.Product return status: 1 device was received.1 device was not available for evaluation.5 device investigation types have not yet been determined.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device was found to be affected by worn component.Additional information: 7 devices were not labeled for single-use.7 devices were not reprocessed or reused.
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Event Description
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This report summarizes 7 malfunction events in which the device was reportedly difficult to open or close.7 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.8 previously reported events are included in this follow-up record.7 events were previously reported during the reporting quarter; however: 1 previously reported event was included under mfr report # 0001811755-2020-02833 but should be included under this report.8 reported events are included in this follow-up record.Product return status: 3 devices were received.5 devices were not available for evaluation.
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Event Description
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This report summarizes 8 malfunction events in which the device was reportedly difficult to open or close.8 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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