(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that the base of light guide is broken.It was also observed the spot welding joint was intact.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturer also reports that the device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.It seems as though the device sustained unexplained physical damage.A root cause could not be determined.Due to an increase in complaints for breakage, a capa was opened to further investigate this issue.
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