The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The device history record review could not be conducted because a lot number was not provided.There were no samples returned to the manufacturing site for evaluation however 2 photographs were received.The reported condition was not visible and could not be confirmed based solely on the photographs.A gemba walk through the manufacturing process was complete, in general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.The investigation did not identify a systemic issue or trend with the product or process therefore, a corrective and preventive action (capa) is not deemed necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.
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