Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint, #(b)(4), was included in the recall.
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Procedure performed: lap-chole event description: complaint 1 of 9: (b)(4), complaint 2 of 9: (b)(4), complaint 3 of 9: (b)(4), complaint 4 of 9: (b)(4), complaint 5 of 9: (b)(4), complaint 6 of 9: (b)(4), complaint 7 of 9: (b)(4), complaint 8 of 9: (b)(4), complaint 9 of 9: (b)(4).Customer wanted to clip the cystic-duct.When preloading, comes no clip out of the applier.Patient status: no injury.Intervention: opened a new one.
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