Model Number 4500-125-000 |
Device Problem
Material Disintegration (1177)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/30/2021 |
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 was received.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device was shedding metal debris.1 event 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: 1 event was previously reported during the reporting period product return status: 1 device was received.Additional information: 1 device was not labeled for single-use.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device was shedding metal debris.1 event had no patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|