(b)(4).Batch # n93f79, n93k3r, lot # p4r064.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.The analysis results found that the b12srt device was returned with the duckbill damaged and torn; the torn piece of the duckbill was returned inside a petri dish.In addition, the tyvek was returned along with the instrument.The device was disassembled in order to evaluate the condition of the duckbill and the damage was confirmed; in addition, the separate piece of the duckbill was observed to have a mark which suggest that a pointy instrument was inserted through the trocar with excessive force.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." the batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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