Complaint alleges that during a lap chole procedure, the clips were stuck in the applier, so the applier was unable to be fired normally for the procedure.It was confirmed that no clips fell into the pt.No pt injury reported.Pt's current condition reported, as fine.
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(b)(4).Device history record (dhr) investigation did not show issues related to this complaint.No corrective actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause.The manufacturer will continue to monitor and trend relating complaints.
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