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 03/31/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 20 malfunction events in which the device was reportedly difficult to open or close.19 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.Reported events; 20 events were reported for this quarter.Product return status; 16 devices were not available for evaluation.4 device investigation types have not yet been determined.Additional information; 20 devices were not labeled for single-use.20 devices were not reprocessed or reused.
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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, h6, h10 20 previously reported events are included in this follow-up record.Product return status 20 devices were not available for evaluation.H3 other text : device not returned.
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Event Description
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This report summarizes 20 malfunction events in which the device was reportedly difficult to open or close.- 19 events had no patient involvement; no patient impact.- 1 event had insufficient information received.
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Search Alerts/Recalls
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