Model Number 7126-120-000 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2022 |
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: 5 events were reported for this quarter.Product return status: 1 device was received.2 devices were not available for evaluation.2 device investigation types have not yet been determined.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
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Event Description
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This report summarizes 5 malfunction events in which the device was reportedly difficult to open or close.4 events had no patient involvement; no patient impact.1 event 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: h10.5 previously reported events are included in this follow-up record.Product return status: 1 device was received.3 devices were not available for evaluation.1 device investigation type has not yet been determined.
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Event Description
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This report summarizes 5 malfunction events in which the device was reportedly difficult to open or close.4 events had no patient involvement; no patient impact.1 event 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 5 previously reported events are included in this follow-up record.Product return status 1 device was received.4 devices were not available for evaluation.
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Event Description
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This report summarizes 5 malfunction events in which the device was reportedly difficult to open or close.4 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
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Search Alerts/Recalls
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