Model Number VORP 503 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/27/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
|
|
Event Description
|
The explanted device was received for investigation.The user was not re-implanted.
|
|
Event Description
|
The explanted device was received for investigation.The user was not re-implanted.
|
|
Manufacturer Narrative
|
Conclusions: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the recipient was a non-user and the device was explanted upon the recipient's request.Based on measurements performed during explant investigation, it must be assumed that the explantation was not due to a technical problem.This is a final report.
|
|
Search Alerts/Recalls
|