Root cause: pin pressure testing showed minimal deviation and did not contribute to the event.The biggest deviation was at the 90n which is below the clinical application use.Suspected root cause: wrong pinning technique.Root cause: failure reported by customer but product is within spec.Device evaluated and alleged failure could not be duplicated.Suspected root cause: wrong pinning technique.Corrective action: instructed customer to properly position the pt's head.Ensure that the 2 skull pins in the rocker arm are equidistant from the centerline of the head and that all 3 pins are penetrating the skull equally.The angle of the pins should be as close to 90 degrees possible to the pt's skull.Test that the skull clamp ext.Arm is fully engaged in the clamp base.Lock the index knob, so that the arrow and "lock" are aligned.See instruction manual, section 6.Device was returned and can be used as intended.Returned product and another copy of the instruction manual to customer.
|