It was reported that the piston irrigation syringe experienced multiple problems/issues.Reportedly, it did not irrigate "successfully," does not suction when pulling back on the plunger, and the stopper "malfunctions." no serious injury or adverse impact to a patient or to a user was originally reported.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.No photo or sample were provided for evaluation.The reported problem/issue was unable to be confirmed and a root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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