Investigation x-no sample returned x-review dhr *analysis and findings *was the complaint confirmed? yes distr.History the complaint product (sn (b)(6)) was manufactured at csi on 12/02/21 under work order (b)(4).Manuf.Record review dhr - 311134 was reviewed and no non-conformity, related to the complaint condition, were noted.Incoming inspect.Review incoming inspection record review not applicable to this product.Serv.Hist.Record no service history record found for this unit.Historical complaint review a review of 2-year complaint history did show similar reported complaint condition - however, those complaints were not confirmed as the units were not returned for investigation product receipt complaint unit was returned.Vis.Eval.Visual examination of the complaint product revealed physical damage.The handle was confirmed to have been detached.The welded joint was present, but its apparent that the weld was broken.Further look into the unit revealed deep dents where the device may have been bumped.Functnl eval.Complaint product was functionally evaluated and found not to function properly.The handle was broken off.Root cause while no definitive root cause could be reliably determined, the potential cause may be that the device may be been mishandled as evidenced by the various dents across the body of the device.The complaint condition appears to be an isolated incident.Each of the individual umh750 are inspected at a 100% during incoming.During the incoming inspection, a functional test is performed to inspect another portion of the unit (unrelated to the complaint failure mode) which requires gripping onto the handle.Had the handle been detached during the time of manufacture, the unit would have been identified and isolated.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as it was determined that there is no verified trends related to this complaint condition.The product met the required release specifications per dhr review.No re-training required.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
|