Catalog Number 3500000710 |
Device Problem
Sharp Edges (4013)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/01/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This mdr is part of the fda voluntary malfunction summary reporting program. the devices were evaluated in the field and the issue was confirmed; there were broken/damaged components. the devices were repaired and returned. there was no remedial action taken. this device is not labeled for single use.
|
|
Event Description
|
This report summarizes 3 malfunction events, where it was reported there were accessible sharp metal edges.There was no patient involvement.
|
|
Search Alerts/Recalls
|