It was reported that the plunger of the irrigation syringe "comes off" during use.At the time of the incident, bladder irrigation was occurring and bladder fluid reportedly leaked onto a surgeon.No serious injury or adverse impact to the user or to a patient 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.A sample was returned for evaluation and both visual and function inspection did not reproduce or confirm the reported problem/issue.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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