Catalog Number 5100015250 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/31/2024 |
Event Type
malfunction
|
Event Description
|
This report summarizes 6 malfunction events in which the device had a component detach.4 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.1 event had insufficient information received.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 6 events were reported for this quarter.Product return status 5 devices were received.1 device investigation type has not yet been determined.Additional information 6 devices were not labeled for single-use.6 devices were not reprocessed or reused.
|
|
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, h1, h6, h11 6 events were previously reported during the reporting period; however, - 1 previously reported event in this report should have been included under mfr report # 3015967359-2024-00789.- 5 previously reported events are included in this follow-up record.Product return status 5 devices were received.
|
|
Event Description
|
This report summarizes 5 malfunction events in which the device had a component detach.- 4 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|