The customer's complaint history was reviewed for the period of one year; this is the first complaint reported for this issue.
There have been no additional complaints reported against the finish goods lot and the dhr shows the product was released per specifications.
The returned sample was visually and functionally tested and passed testing.
The infiniti vision system operator's manual provides the following in regard to loss of aspiration: insufficient aspiration.
Probable cause: loose blue luer fittings.
Damaged o-ring (ultraflow i/a handpiece only).
Kinked or damaged tubing.
Cracked blue fitting.
Corrective action: reconnect securely.
Inspect o-ring and replace, as necessary.
Flush tip with sterile water or bss sterile irrigation solution.
Checking tubing and/or replace fms.
Check fitting and/or replace fms.
The root cause of the customer's complaint is not known; the returned sample met specifications.