(b)(4).Batch # p91c2z.Device analysis: the analysis results found that the ctb12lt instrument was received with the tip of the sleeve broken.One potential cause for the damage found may be the inadvertent application of excessive force or torquing during insertion into the abdominal cavity.We have documented the circumstances as they were reported to us.In addition, complaint information is trended on a regular basis to determine if further investigation is warranted.A manufacturing record evaluation was performed for the finished device p91c2z batch number, and no non-conformances were identified.
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