This is filed to report unstable arm positioner.It was reported that during device preparation, the arm positioner was not acting in a normal fashion.There was no hard stop upon closing the device, the arm positioner would continue to rotate far after the clip was closed.There was no patient involvement and the device was exchanged for a new one.No additional information was provided.
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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 reported from this lot.The investigation was unable to determine a cause for the reported arm positioner issue.There is no indication of a product issue with respect to manufacture, design, or labeling.
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