|
Catalog Number 72200616S |
Device Problems
Overheating of Device (1437); Device Contamination with Chemical or Other Material (2944); Mechanical Jam (2983)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/25/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The reported complaint of overheating could not be confirmed.Product was not burned out, nor did it overheat during functional testing.Unit was tested at speed settings of between 500 and 10,000 rpms in forward and reverse.The oscillate function was tested for 5 minutes of continuous performance with no overheating.Test blade did not melt when used correctly with irrigation.Product was tested on a known good dyonics power, dii, and dii eip control units with and without footswitch.At no time did mdu overheat or lock up.All functions perform as expected.No problem found.(b)(4).
|
|
Event Description
|
It was reported the motor drive unit hand cntrl pwrmx el got hot, seized up, and black soot came out near the blade.There was a delay of less then 30 minutes.This occurred during the procedure.A backup device was available and used to complete the surgery.No patient injuries were reported.
|
|
Search Alerts/Recalls
|
|
|