It was reported that during preparation, after establishing final arm angle, the clip was difficult to open and the clip arms jumped open.The physician stated that while turning the arm positioner, resistance was felt.Therefore, the physician decided to not use the clip and replace it.There was no clinically significant delay in the procedure.
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The device was not returned for analysis.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 from the lot.All available information was investigated and based on the information provided and without the device to analyze, a cause for the reported difficult to open or close associated with difficulty opening the clip, jumpy clip and physical resistance/sticking of the arm positioner could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.
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