The complaint device was returned to stryker sustainability solutions for evaluation.Inspection of the returned device revealed clinical use including biological material on the distal tip and indention in the teflon pad.The shaft rotation and the jaw actuation of the device were found to be acceptable.The device was connected to a generator and passed the initial testing.The device was successfully activated with the foot pedals and buttons.Each time the min or max button or pedal was pressed, the device activated and at no time during testing did the device stop working.The device was examined further and a build up of fluid was noticed along the rod which can disrupt harmonic frequency and reduce cutting ability.The rod was inspected for fractures, and none were found.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid to rise up the rod.The cause of tissue/fluid build up is damage to the distal gasket; action is being taken to address this issue.Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability; therefore, the reported complaint was confirmed.
|