It was reported during preparation, while testing the actuation of an xt clip, one of the grippers would not lower.It was observed the gripper line was missing.Therefore, the clip was not used and replaced.There was no clinically significant delay in the procedure.
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All available information was investigated, and the reported unable to lower gripper was confirmed via returned device analysis.The reported missing gripper line was not confirmed via returned device analysis.Additionally, a broken gripper line was observed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and the returned device analysis, the cause of the reported missing gripper line was undetermined.The reported unable to lower gripper was a cascading event of the observed broken gripper line.The investigation determined the observed broken gripper line to be related to a potential product quality issue.This complaint is within the scope of an exception escalation as the complaint description and device code match the specific issue described in the exception.Therefore, two exceptions (issues) are referenced.The investigation evaluated the reported issue, and the engineering group was unable to determine a root cause.The potential contributing factor of method was found due to possible introduction of kinks during manufacturing process.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
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