Reference : e-complaint-(b)(4).Investigation x-review dhr x-inspect returned samples.Analysis and findings distribution history: this complaint unit was manufactured at csi on 12/16/15 under wo #'s (b)(4) and shipped on 12/17/15.Manufacturing record review: dhr's (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the attached 2-year complaint history showed one similar reported complaint condition.The complaint was not confirmed.Product receipt: the complaint unit was returned on a repair.However, based on log 92217, this unit was at csi on 6/18/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Service & repair did not confirm the complaint unit.This unit's main board was noted to have no zener diode and updated regardless of being non-rohs.A recall (1216677-05-24-2019-002-r) has been issued for foot pedal activation failures primarily detected on rohs boards.A review of the occurrence pinpointed the update to rohs resulted in instances of foot pedal failures and addressed by the recall and capa 725.This unit was not on complaint for this failure.Root cause : the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action the unit was updated with the zener diode, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? no.*preventative action activity coopersurgical will continue to monitor this complaint condition for any trends.
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