AquaBeam Handpiece 310301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B6143103011), received between Nov 8, 2019 and Nov 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AT THE END OF AN AQUABLATION PROCEDURE, UPON TAKING THE AQUABEAM HANDPIECE OUT OF THE PATIENT, THE ASPIRATION AND IRRIGATION TUBES PARTIALLY DETACHED FROM THE MANIFOLD. THE PHYSICIAN WAS ABLE TO FULLY PULL THE AQUABEAM HANDPIECE OUT OF THE PATIENT AS IS WITHOUT ADDITIONAL INTERVENTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9298871 ↗