H3: evaluation determined that the device was tested and the maximum temperature was measured to be 140 degrees fahrenheit.The likely cause was identified as collet and motor bearings are worn.It was also noted that laser markings are faded, stator was loose."date of notification: 2024-02-02" medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|