Updated: device avail.For eval., returned to mfr.On., device returned to mfr., device evaluated by mfr., eval summary, method codes, results codes, conclusion codes.Device evaluated by manufacturer - the foot guard was in overall good physical condition.The strain relief guard over cord was in good physical shape.No damage was noted to the cord¿s insulation jacket.The pedal presses down evenly with normal clicking sound.The connector to maestro is in good physical shape.Pins are straight and grounding shield is intact.Using an ohm meter the foot switch was placed on the floor and activated.The switch turned on off with no issues.The cord was pulled and flexed along the length and near the connector and pedal¿s strain reliefs.No issues observed.The foot switch passed all electrical and functional testing.When removing the foot pedal¿s cover, the trigger mechanism could move out of place.However, when the cover was put back on, the trigger mechanism moved back to the correct orientation.A service history review was performed on the rf ablation foot switch.There was found nothing to indicate any possible service-related causes for the complaint.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
|