Reference e-complaint-(b)(4).Investigation: x-initiated manufacturer's investigation and x-review dhr.Analysis and findings: the complaint was logged to a kcs-rumi-35 with lot number 260947.Lot 260947 pertains to kc-rumi-35 and not a kcs-rumi-35.As indicated in the complaint details, the customer had ordered a kcs-rumi-35, however, a kc-rumi-35 was delivered instead.The lot number provided (260947) verifies that the product delivered was the kc-rumi-35.The customer used the kc-rumi-35 as a kcs-rumi-35 using a harmonic cutter and caused the plastic to melt.A kcs-rumi-35 has a metal ring specifically designed to be used with a harmonic scalpel and would have prevented melting of the product.Therefore, this complaint is not a manufacturing defect, as the product was not used as intended.In addition to this, there appears to have been an order fulfillment issue, as the customer had requested for a kcs-rumi-35, while a kc-rumi-35 was delivered.Dhr review of wo# (b)(4) for pn kc-rumi-35 shows 100 boxes were made in dec 2018 at csi stafford facility and there were no non-conformances.A 2 year complaint history review was performed and did not see other similar complaints pertaining to the cup melting.Correction and/or corrective action: this complaint will be monitored for trending.Not determined to be a manufacturing issue.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.
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