AquaBeam Handpiece HP2000 (UDI B614HP2000X1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B614HP2000X1), received between Dec 22, 2023 and Oct 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR" WHEN CONNECTING THE AQUABEAM HANDPIECE TO THE AQUABEAM MOTORPACK. THE E22 ERROR WAS CLEARED. DURING NOZZLE REGISTRATION THE AQUABEAM ROBOTIC SYSTEM GENERATED ANOTHER "E22 - MOTORPACK ERROR". THE ERROR WAS AGAIN CLEARED. DURING THE FIRST TREATMENT PASS, THE AQUABEAM ROBOTIC SYSTEM GENERATED MULTIPLE "E22 - MOTORPACK ERROR", "E23 - MOTORPACK ERROR", AND "E31 - MOTORPACK ERROR". AFTER TROUBLESHOOTING, THE FIRST TREATMENT PASS WAS ABLE TO BE COMPLETED. DURING THE SECOND TREATMENT PASS, THE AQUABEAM ROBOTIC SYSTEM GENERATED MULTIPLE "E22 - MOTORPACK ERROR", "E23 - MOTORPACK ERROR", AND "E31 - MOTORPACK ERROR". AS A RESULT, THE TREATING SURGEON DECIDED TO USE A BIPOLAR LOOP TO FINISH THE TREATMENT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433942 ↗
• MalfunctionDec 22, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING JET ALIGNMENT, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR" MESSAGE. A SECOND AQUABEAM HANDPIECE WAS USED WHICH RESOLVED THE ISSUE AND THE AQUABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THE REPORTED EVENT CAUSED A SURGICAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384528 ↗