Investigation review dhr inspect returned samples.Distribution history the complaint product was manufactured at csi in june 2021 under work order (b)(4).Manufacturing record review dhr21dsp003567 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for 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 was returned.The lot number of the returned product matched the lot number reported.Visual evaluation visual examination of the complaint product revealed no physical damage.It was noticed the metal rod, which is inserted in the tip at the assembly operation, was removed from the tip.The metal rod is used to connect to the handle.Functional evaluation complaint product was functionally evaluated and found to function properly.The balloon inflated as normal.Root cause it should be noted that each tip is 100% tested during production to ensure the balloon inflates properly.Finished goods inventory for the reported lot number is depleted.As described above, it was noticed the metal rod, which is inserted in the tip at the assembly operation, was removed from the tip.The metal rod is used to connect to the handle.It is not clear if this caused the reported condition.This complaint condition is considered an isolated incident.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.Was the complaint confirmed? yes.
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