AquaBeam Handpiece HP2000 (UDI B614HP20001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B614HP20001), received between Dec 20, 2021 and Jul 12, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING THE AQUABLATION PROCEDURE, THE AQUABEAM SCOPE WAS UNABLE TO PROVIDE A CLEAR VISUALIZATION. MULTIPLE TROUBLESHOOTING STEPS WERE MADE TO ADDRESS THE ISSUE WITHOUT AVAIL. AS A RESULT, THE SURGEON DECIDED TO ABORT THE AQUABLATION PROCEDURE AND CONVERTED TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) SURGERY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309931 ↗
• MalfunctionApr 6, 2023Display or Visual Feedback Problem; Visual Prompts will not Clear; Display or Visual Feedback Problem; 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 THE SECOND TREATMENT PASS AN "E22 - MOTORPACK ERROR" WAS GENERATED BY THE AQUABEAM ROBOTIC SYSTEM. MULTIPLE TROUBLESHOOTING STEPS WERE TAKEN IN AN EFFORT TO RESOLVE THE ISSUE, WHICH WAS MOMENTANEOUSLY RESOLVED BUT THE ERROR PERSISTED. AS A RESULT, THE AQUABLATION PROCEDURE WAS ABORTED DUE TO POSITIVE RESULTS WITH THE AMOUNT OF RESECTION OF THE BLADDER TISSUE PREVIOUSLY PERFORMED. UPON FURTHER INSPECTION, IT WAS THEN OBSERVED THAT THE LITHOTOMY DRAPE COVERING THE MOTORPACK WAS BUNCHED UP, CAUSING THE MOTORPACK TO DISENGAGE UPON OPERATION. NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16694777 ↗
• InjuryJul 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT THE PATIENT WAS INCONTINENT POST AQUABLATION PROCEDURE (PER MANUFACTURER'S INSTRUCTIONS FOR USE INCONTINENCE OR OVERACTIVE BLADDER ARE IS A PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. ADDITIONAL INFORMATION REGARDING CURRENT PATIENT'S CONDITION IS BEING REQUESTED.

  Patient problems: Urinary Incontinence

  MAUDE report 15036928 ↗
• MalfunctionMar 3, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING THE AQUABLATION PROCEDURE, AND WHILE PRIMING THE AQUABEAM HANDPIECE, AN "E05 - CONSOLE ERROR" MESSAGE WAS GENERATED BY THE AQUABEAM ROBOTIC SYSTEM. AFTER MULTIPLE TROUBLESHOOTING STEPS WERE PERFORMED, THE PROCEDURE WAS ABLE TO BE CONTINUED THROUGH SUCCESSFUL COMPLETION. THE REPORTED EVENT CAUSED A PROCEDURAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660207 ↗
• MalfunctionDec 20, 2021Connection Problem; Connection Problem

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING THE AQUABLATION DIFFICULTY WAS ENCOUNTERED ENGAGING THE AQUABEAM HANDPIECE PUMP CARTRIDGE TO THE AQUABEAM CONSOLE. SEVERAL TROUBLESHOOTING STEPS WERE PERFORMED WITHOUT RESOLVING THE ISSUE. THE AQUABEAM HANDPIECE WAS REPLACED WITH A NEW HANDPIECE UNIT AND THE AQUABLATION PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. THE REPORTED EVENT CAUSED A PROCEDURAL 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 13049199 ↗