It was reported that prior to an unknown procedure, the customer complains about the quality of the device they recently purchased.It was complained that the jaws of the device do not align properly, and the length of the two jaws/legs in each device vary.Each of the devices returned varies significantly in terms of the length of the legs, the sizes of the finger ring, the grooves within the jaws, etc., suggesting poor quality control.Functional test was performed and some of the devices could not form clips properly.The closed clips ended up with one long and one short leg, or scissors legs.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.
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(b)(4).The analysis results found that the lx107 device was received in good visual condition.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended.The instrument was fully functional and conforming to our manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.
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