Model Number TABLETOP |
Device Problem
Optical Problem (3001)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/17/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A customer reported the illumination ports were too dark.Additional information has been requested and received indicating the event occurred during a cataract extraction procedure.He procedure was completed with no impact to the patient.Service was requested and performed.The system is performing fine.
|
|
Manufacturer Narrative
|
The company service representative examined the system and replicated the reported event.The illuminator module was replaced to resolve the issue.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The illuminator module was received and evaluated.Per the sample evaluation, the issue was replicated.The illuminator controller printed circuit board (pcb) in the illuminator module was found to be nonconforming.The root cause of the reported event can be attributed to nonconforming illuminator controller printed circuit board (pcb) the manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|