It was reported that the piston irrigation syringe separated.The separation occurred while pulling back on the syringe.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.A returned sample and a comparative sample from stock were used in the evaluation of the reported problem/issue.Dimensional analysis found that the diameter of the rubber grommet was slightly under the required specification by an average of approximately 0.25mm.A brief functional evaluation was done on the samples by simulating an environment where a great amount of suction was produced on the plunger.It was observed that during these conditions, the grommet would detach from the plunger and remain inside the barrel of the piston irrigation syringe.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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