(b)(4).Per dhr the product visistat 35w 6/box lot # 73b2100290 was manufactured on 02/09/2021 a total of 18,000 pieces.Lot was released on 02/18/2021.Dhr investigation did not show issues related to complaint.P/n 528235 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 13 staplers were taken from the current production from p/n 528236 visistat 35w non-sterile lot# 73m2100230 the staplers were functionally inspected and issue reported "failure to function - other" was not observed in the current manufacturing process, the staples were loaded and released correctly.Revision of fmea-08-028 rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.
|