Catalog Number 0250070600 |
Device Problems
Complete Blockage (1094); Suction Problem (2170)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
|
|
Event Description
|
It was reported that the device clogged.
|
|
Event Description
|
It was reported that the device clogged.
|
|
Manufacturer Narrative
|
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: today i had a customer that is very familiar with our ahto irrigator go through 4 consecutive ahto tubesets because of clogging in the body of the handpiece during suction.The issue was resolved when a different lot number was pulled.The probable root cause could bio burden substance from the use of the instrument port, or normal use.
|
|
Search Alerts/Recalls
|