Catalog Number 5407120950C |
Device Problem
Flaked (1246)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/31/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 9 events were reported for this quarter.Product return status 9 devices were evaluated in the field.Additional information 9 devices were not labeled for single-use.9 devices were not reprocessed or reused.
|
|
Event Description
|
This report summarizes 9 malfunction events in which the device had paint chips missing.- 9 events had no patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
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 9 events were originally reported for this failure mode during the reporting quarter; however, - 1 events were inadvertently excluded.- 10 reported events are included in this follow-up record.Product return status 10 devices were evaluated in the field.Additional information 10 devices were not labeled for single-use.10 devices were not reprocessed or reused.
|
|
Event Description
|
This report summarizes 10 malfunction events in which the device had paint chips missing.- 10 events had no patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|