Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.With the limited information available and the unavailability of the device for analysis, no further analysis or investigation was possible.A review of all information available for consideration at the time of this investigation was insufficient to confirm the reported event and determine the exact cause.It is notable that there is no evidence of any specification non-conformances related to the complaint device.The most probable root cause was unable to be determined.(b)(4).
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