The device was not returned for evaluation.Therefre, we could not conclusively determine the root cause of the reported incident.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.Due to similar issues reported we have previously initiated a capa to further investigate the reported issue.Please note that this is report 2 of 2.Report 1220948-2023-00081 was submitted for the remaining device related to this incident.
|