It was reported that during handpiece calibration before a demo case, the customer opened the handpiece and noticed that the black rubber stopper was not in the middle of the pillar.The rubber was positioned but was noticed that the silver cylinder within the handpiece that houses the long attachment did not move independently from the gears on the motor.A new handpiece was used in order to continue with the demo.The device was not being used with a patient during the event.The results of the investigation have concluded that the problem is caused by the material used to manufacture one of the snaplock components, which makes it the root cause of the device malfunction.Results of the investigation have concluded that the snaplock assembly was damaged, which makes it a reportable event.
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H10 h3, h6: the navio handpiece, intended for use in treatment, had homing failure prior to a procedure on (b)(6) 2015.The navio handpiece was not returned for further evaluation and a visual/functional inspection could not be performed.During an internal analysis, the problem was determined to be caused by the material used to manufacture one of the snap lock components.The material used by one of the suppliers is displaying properties after autoclave sterilization that may cause the snap lock assembly to become tight.This handpiece had a snap lock from one of the affected lots.The root cause of this issue was found to be supplier/raw material fault.A device history record review found the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.
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