H3, h6: the navio handpiece pfsr 110137, sn(b)(6), used for treatment was returned for evaluation.The reported issue could not be confirmed.Nothing was identified visually that contributed to the reported problem.Functional evaluation found that the device passed all tests and functioned as expected.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.There were no indications of an issue that would potentially lead to a future performance issue.A complaint history review found similar reports, this issue will continue to be monitored.No problem found with the device.It was reported that the device thrust stopped working during a case.It is possible that there was debris caught in the device, causing a jam, which was cleared when the handpiece was sterilized.No further containment or corrective actions are recommended at this time.
|