AquaBeam Robotic System AB2000CRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI B614AB2000C1), received between Jul 10, 2023 and Mar 20, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (1 report).

1 other recall cover devices cleared under the same FDA submission (K202961); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION PROCEDURE, THE PATIENT IS EXPERIENCING EJACULATORY DYSFUNCTION (PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, SEXUAL DYSFUNCTION, INCLUDING EJACULATORY AND ERECTILE DYSFUNCTION ARE POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE). THE TREATING PHYSICIAN IS GOING TO OBSERVE THE PATIENT FOR THIS ISSUE AND HAS ASSESSED THE EVENT AS RELATED TO THE PROCEDURE. THE EVENT WAS REPORTED AS MILD AND NON-SERIOUS, WITH NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM REPORTED.

  Patient problems: Sexual Dysfunction

  MAUDE report 18942457 ↗
• InjuryDec 22, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM DUE TO BLEEDING, WHICH WAS ADDRESSED WITH CLOT EVACUATION. THE ISSUE IS REPORTED TO HAVE BEEN RESOLVED WITHOUT SEQUELAE. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18384545 ↗
• InjuryNov 7, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT THE PATIENT HAD PRESENTED WITH URINARY TRACT INFECTION WHICH WAS TREATED WITH ANTIBIOTICS. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 18085369 ↗
• InjuryNov 7, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION TREATMENT, THE PATIENT EXPERIENCED URINARY RETENTION WHICH WAS TREATED WITH CATHETERIZATION. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE UNRELATED TO THE PROCEDURE OR DEVICE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 18083513 ↗
• InjuryNov 7, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION TREATMENT, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION WHICH WAS TREATED WITH ANTIBIOTICS. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED AND ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 18083470 ↗
• InjuryOct 17, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION TREATMENT, THE PATIENT EXPERIENCED URINARY RETENTION WHICH WAS TREATED WITH CATHETERIZATION. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 17952954 ↗
• InjuryOct 17, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION TREATMENT, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION WHICH WAS TREATED WITH MEDICATION AND CATHETERIZATION. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17952408 ↗
• InjuryOct 17, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION TREATMENT, THE PATIENT EXPERIENCED DYSURIA WHICH WAS TREATED WITH MEDICATION. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Dysuria

  MAUDE report 17951927 ↗
• InjuryOct 16, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION TREATMENT, THE PATIENT EXPERIENCED EJACULATORY DYSFUNCTION. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Sexual Dysfunction

  MAUDE report 17938931 ↗
• InjuryOct 13, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT THE PATIENT HAD PRESENTED WITH EJACULATORY DYSFUNCTION (PER MANUFACTURER INSTRUCTIONS FOR USE, SEXUAL DYSFUNCTION, INCLUDING EJACULATORY AND ERECTILE DYSFUNCTION ARE POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE). IT WAS REPORTED THAT THE TREATING PHYSICIAN WAS TO MONITOR THE PATIENT'S CONDITION. THE PHYSICIAN DETERMINED THAT THE EJACULATORY DYSFUNCTION WAS RELATED TO THE PROCEDURE AND UNLIKELY RELATED TO THE DEVICE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Sexual Dysfunction

  MAUDE report 17934955 ↗
• InjuryOct 13, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT THE PATIENT HAD PRESENTED WITH BLEEDING AND ACUTE URINARY RETENTION (PER MANUFACTURER'S INSTRUCTIONS FOR USE, URINARY RETENTION IS A PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH MEDICATION AND CATHETERIZATION. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE LIKELY RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Retention

  MAUDE report 17934949 ↗
• InjuryOct 13, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT THE PATIENT HAD PRESENTED WITH EJACULATORY DYSFUNCTION (PER MANUFACTURER INSTRUCTIONS FOR USE, SEXUAL DYSFUNCTION, INCLUDING EJACULATORY AND ERECTILE DYSFUNCTION ARE POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE) AND HEMATURIA. IT WAS REPORTED THAT HEMATURIA WAS TREATED WITH MEDICATION AND CATHETERIZATION, WHILE THE TREATING PHYSICIAN WAS TO MONITOR THE PATIENT'S CONDITION FOR EJACULATORY DYSFUNCTION. THE PHYSICIAN DETERMINED THAT THE EJACULATORY DYSFUNCTION WAS RELATED TO THE PROCEDURE AND UNLIKELY RELATED TO THE DEVICE, AND ASSESSED THE HEMATURIA AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hematuria; Sexual Dysfunction

  MAUDE report 17934923 ↗
• InjuryAug 1, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT TWO MONTHS POST-AQUABLATION TREATMENT, THE PATIENT PRESENTED WITH SEPSIS. THE PATIENT WAS GIVEN ANTIBIOTICS AND A CATHETER WAS PLACED, WHICH RESOLVED THE REPORTED ISSUE WITHIN 2 DAYS FROM THE INITIAL OCCURRENCE. HOWEVER, THE ROOT CAUSE OF THIS EVENT REMAINS UNIDENTIFIED. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE LIKELY RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Sepsis

  MAUDE report 17436203 ↗
• InjuryJul 26, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION TREATMENT, THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AND ASSESSED THE EVENT TO BE LIKELY RELATED TO THE PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17398160 ↗
• MalfunctionJul 10, 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 DURING THE AQUABLATION PROCEDURE, MULTIPLE "E208 - MOTORPACK ERROR" MESSAGES WERE GENERATED BY THE AQUABEAM ROBOTIC SYSTEM. MULTIPLE TROUBLESHOOTING STEPS WERE PERFORMED TO RESOLVE THE ISSUE WITHOUT SUCCESS. HOWEVER, ONCE THE POWER REACHED 80%, THE OCCURRENCE OF ERROR CODES CEASED AND THE PROCEDURE WAS CONTINUED THROUGH SUCCESSFUL COMPLETION. 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 17288561 ↗
• InjuryJul 10, 2023Adverse 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 (PROCEPT) BECAME AWARE THAT POST-AQUABLATION PROCEDURE THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) FOR CLOT EVACUATION AND FULGURATION. THE PATIENT'S HEMOGLOBIN (HB) LEVEL WAS 130 G/DL, WITH NO BLEEDING VESSELS, AND WAS DISCHARGED HOME THE NEXT DAY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17288558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K202961. One submission often covers many models, so check the product and lot details in each record.

• Z-2330-2021 · Jul 9, 2021 · Open, Classified
  AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.