Investigation: review dhr inspect returned samples.*analysis and findings.Distribution history.The lot number of the products used are unknown however the customer sent back a sampling of their inventory.The complaint products were manufactured at csi.Manufacturing record review a specific lot number was not provided by the customer however, according to the sample sent: dhr-2030 - 619009267, dhr-2030 - 619009266, dhr-2030 - 619020360, dhr-2030 - 619009265, and dhr-2030 - 619003833, dhr-2030 - 619007795, dhr-2030 - 619008193, dhr-2030 - 619003118 were 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 showed similar reported complaint conditions were the stapler stopped working.Product receipt.The complaint products were returned on 10/05/22.The lot number of the returned products were: received lot number quantity: 619009267 6; 619009266 6; 619010360 6; 619009265 5; 619003833 2; 619007795 1; 619008193 1; 619003118 1.Visual evaluation packaging: all returned product was verified to have no breach to the sealed packaging.Seal condition: the returned product was verified to display a minimum 1/8 inch seal.Desiccant packs: the desiccant packs did not indicate prolonged exposure to moisture.Storage conditions: outer box with temperature indicator was not returned.Visual examination of the complaint products revealed no physical damage.Functional evaluation the complaint products were functionally evaluated and tested by the quality inspectors and a report was issued for every lot number provided (see attachments) and were found to function properly.In lot 619009265 one of the staplers presented 2 staples that failed the penetrator gap and staple measurements by 0.001 inch, but the rest were found to function properly.All the staplers were completely fired and found to function correctly.Root cause.No definitive root cause for this issue could be reliably determined at this time as the faulty lot numbers were not provided.However, it is worth mentioning that the returned products tested to specification.*correction and/or corrective action.No further corrective action is necessary, as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.*was the complaint confirmed? no.
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