Catalog Number 0210114100 |
Device Problem
Disassembly (1168)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/25/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that the interpulse handpiece with coaxial high flow tip broke into two pieces during testing.There was no patient involvement, and there were no user injuries or adverse consequences.
|
|
Event Description
|
It was reported that the interpulse handpiece with coaxial high flow tip broke into two pieces during testing.There was no patient involvement, and there were no user injuries or adverse consequences.
|
|
Manufacturer Narrative
|
A follow up report will be filed after the device is received and the quality investigation has been completed.Not yet received by manufacturer for evaluation.
|
|
Manufacturer Narrative
|
The device was evaluated and the reported event was confirmed.The device was scrapped at the manufacturer.
|
|
Search Alerts/Recalls
|