MDT POWERED SURGICAL SOLUTIONS MOTOR MR8 ELECTRIC REFURB; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
|
Back to Search Results |
|
Model Number EM800-R |
Device Problems
Overheating of Device (1437); Vibration (1674)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/05/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3:product analysis: evaluation determined that the device was overheating and the maximum temperature was measured to be 143.3°f.The likely cause of failure could not be determined.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.
|
|
Event Description
|
Repair request initiated for device with the report of chatter and overheating.It was reported there was no patient involvement.Repair request escalated to product event due to return in less than 90 days from purchase or repair and due to reason for return.
|
|
Manufacturer Narrative
|
D4: initial provided serial number (b)(6) is incorrect, received correct the serial number and updated the info to (b)(6).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.
|
|
Search Alerts/Recalls
|
|
|