Model Number EG29-I10C |
Device Problems
Moisture Damage (1405); Optical Distortion (3000); Unintended Movement (3026)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/19/2021 |
Event Type
malfunction
|
Event Description
|
Foggy image, moisture under led cover glasses.This event occurred at the time of during inspection.There was no report of patient harm.
|
|
Manufacturer Narrative
|
This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.If additional information becomes available, a supplemental report will be filed with the new information.
|
|
Manufacturer Narrative
|
Evaluation summary: this device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.We checked the returned unit and confirmed that the ccd module defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
|
|
Search Alerts/Recalls
|