The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations and no non-conformances initiated with this lot code.The actual sample involved in the reported incident was not returned for evaluation.No additional information, photographs or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation and confirm the reported condition.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.
section d4: per the investigation site, the lot number originally reported as 1924101184 is not a valid lot number and the actual lot number is 1924101164 therefore the lot number has been updated.
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