Device was used for treatment, not diagnosis.Additional product code: gxl.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device was used for treatment, not diagnosis.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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A service history was conducted.The report indicates that the past three years has been reviewed.The item was previously returned for service on 25-nov-2013 due to motor failure.The customer called in a service request for this item on 6-jan-2015 and reported the device will not turn off.The previous service condition of motor failure is relevant to the current complained issue of the device will not turn off.The manufacture date of this item is 27-sep-2011.The source of the manufacture date is the release to warehouse date.The service history evaluation is confirmed.Additional evaluation was conducted.The report indicates that the customer reported the report was running continuously.The repair technician reported the nose cone was sticking and binding.Binding is the reason for repair.The cause of the issue is unknown.The following parts were replaced: set screw, motor/gearhead barrier, housing barrier, collet spring, nose cone, cam screw, membrane switch and flex circuit, column o-ring, circuit board, motor, membrane switch/flex circuit, and all applicable components.This item was repaired, passed synthes final inspection and returned to the customer on 21-jan-2015.The evaluation was confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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