Model Number KE001 |
Device Problem
Separation Failure (2547)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/30/2022 |
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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information; 1 device was labeled for single-use.1 device was not reprocessed or reused.Device not returned.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device reportedly failed to separate.- 1 event had insufficient information received.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device reportedly failed to separate.1 event had 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: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was evaluated in the field.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device or one of its components failed to detach or separate as intended.1 event had 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: 1 previously reported event is included in this follow-up record.Product return status: 1 device was evaluated using data provided by the user or a third party.
|
|
Search Alerts/Recalls
|