MEDTRONIC XOMED INC. IPC® HANDPIECE - STYLUS TOUCH®; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
|
Back to Search Results |
|
Model Number EM210 |
Device Problems
Overheating of Device (1437); Noise, Audible (3273)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3: analysis found that temperature test could not be performed due to intense abnormal noise.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
It was reported that during use, the stylus touch handpiece had abnormal sounds and overheating issue.There was no known patient impact.
|
|
Manufacturer Narrative
|
H3: service report of the product received and found that the handpiece was noisy and overheating.Internal parts that were observed to deteriorate, including the motor.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
|
Additional information received stating that the device was run under forward mode and spare was used to completed the remaining procedure.And there was no patient impact associated with the event.
|
|
Search Alerts/Recalls
|
|
|