Investigation x-initiated manufacturer's investigation x-no sample returned x-review dhr *analysis and findings distribution history the complaint product was manufactured at csi on 11/17/21 under work order 312201.Manufacturing record review dhr - 312201 was reviewed and no non-conformity, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.A picture was provided showing that the cup had become detached from the hinge.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation nor verification.With the information provided, a root cause analysis cannot be definitively performed.It is unknown if the customer used a sizer (kcp) to determine the proper size koh-efficient to use.This is listed under the dfu of the product (archkohadv-dfu).The customer was reached for additional information on the procedure and how the device may have been used, however, no information was provided.As a way of improving the manufacturing process, csi stafford has implemented 100% in process inspection of the product via bend testing and pull testing, followed by an aql qc inspection requiring the that the units also pass a bend and pull test.*correction and/or corrective action no further corrective action is necessary, as the complaint was not confirmed.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
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