AquaBeam Handpiece HP2000 (REF HP2000-D)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850055427006), received between Dec 22, 2023 and Jan 10, 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 18, 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.

• MalfunctionJan 10, 2024Visual 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 RECURRENT "E22 - MOTORPACK ERROR", "E50 - CONSOLE ERROR", AND "E31 ERROR" MESSAGES WITH TWO (2) AQUABEAM HANDPIECES. SUBSEQUENTLY, THE TREATING SURGEON ELECTED TO CONVERT THE PROCEDURE TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483561 ↗
• 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 AQUABEAM MOTORPACK CONNECTION, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR" MESSAGE WHICH WAS ABLE TO BE CLEARED. ONCE AQUABLATION TREATMENT BEGAN, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR" MESSAGE AGAIN. MULTIPLE TROUBLESHOOTING STEPS WERE PERFORMED TO CLEAR THE ERROR MESSAGE; HOWEVER, THE ERROR MESSAGE PERSISTED. A SECOND AQUABEAM HANDPIECE WAS USED; HOWEVER, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR" MESSAGE. A THIRD 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 18384476 ↗