The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/25/2021.H.6.Investigation: three photos and three samples were provided to our quality team for investigation.Through visual inspection of the photos, brown stains are observed, however, there was no evidence of rust or corrosion on the samples returned.A review of the device history was performed for the lot 2001005, no deviations or nonconformities were identified during the manufacturing process that could have contributed to this problem.Five retained samples of the lot 2001005 were used for additional evaluation.Using magnification, the product was visually inspected and no corrosion or other staining was observed.Product is visually and functionally inspected throughout the manufacturing process in accordance with procedure, verifying that all critical dimensions are within specification and that there are no product damages or defects.All records have been reviewed and no problems were identified during the inspections of the reported batches.Based on the available information, we are unable to identify a definitive root cause at this time.
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