AquaBeam System 210101Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B6142101011), received between May 2, 2018 and Sep 4, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT POST AQUABLATION THERAPY, THE PATIENT IS EXPERIENCING SEXUAL DYSFUNCTION. THE INITIAL REPORTER (CONSUMER) ENDED THEIR PHONE CALL WITH THE PROCEPT BIOROBOTICS CORPORATION REPRESENTATIVE BEFORE ANY ADDITIONAL DETAILS COULD BE OBTAINED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Sexual Dysfunction

  MAUDE report 20141410 ↗
• InjuryJun 11, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE. DURING THE AQUABLATION PROCEDURE, A RECTAL PERFORATION OCCURRED WITH A TRANSRECTAL ULTRASOUND (TRUS) PROBE (PER MANUFACTURER'S INSTRUCTIONS FOR USE, RECTAL PERFORATION IS A POTENTIAL PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). THE TRANSRECTAL ULTRASOUND (TRUS) PROBE IS A NON-PROCEPT BIOROBOTICS' DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED ON THIS EVENT. NO MALFUNCTION OF THE AQUABEAM SYSTEM WAS REPORTED.

  Patient problems: Bowel Perforation; Perforation

  MAUDE report 10146676 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE. POST-AQUABLATION PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO RECEIVE A TRANSFUSION OF SIX (6) UNITS OF PACKED RED CELLS (PRBCS). THE PATIENT HAD A MEDICAL HISTORY OF BEING ON ELIQUIS ANTICOAGULANT MEDICATION, WHICH WAS STOPPED TWO (2) DAYS PRIOR TO THE AQUABLATION PROCEDURE (PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, PATIENTS MUST BE ABLE TO SAFELY STOP ANTICOAGULANT AGENTS BEFORE SURGERY). THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION WITH NO FURTHER CLINICAL SEQUELA. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10105404 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE. THE PATIENT HAD A MEDICAL HISTORY OF BEING ON LEVONOX AND PRADAXA ANTICOAGULANT MEDICATIONS (PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, PATIENTS MUST BE ABLE TO SAFELY STOP ANTICOAGULANT AGENTS BEFORE SURGERY). TWENTY-FOUR HOURS POST DISCHARGE, THE PATIENT WAS READMITTED DUE TO BLEEDING (PER MANUFACTURER'S INSTRUCTIONS FOR USE, BLEEDING IS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE). THE PATIENT RECEIVED A BLOOD TRANSFUSION (NUMBER OF UNITS UNKNOWN) AND WAS REPORTED TO BE IN GOOD CONDITION WITH NO FURTHER CLINICAL SEQUELA. NO MALFUNCTION OF THE AQUABEAM SYSTEM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS PUT BACK ON LEVONOX AND PRADAXA APPROXIMATELY AFTER 12 HOURS POST-SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9860862 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN AQUABLATION PROCEDURE, DURING CLOT EVACUATION AND UROLIFT CLIPS REMOVAL, A PATIENT HAD SYMPTOMS OF BRADYCARDIA, AND A ST-SEGMENT DEPRESSION MYOCARDIAL INFARCTION (A SILENT MI). THE PATIENT MAY ALSO HAVE HAD A BRIEF RUN OF VENTRICULAR TACHYCARDIA. A MEDICAL RESPONSE TEAM WAS CALLED TO TREAT THE PATIENT. THE PATIENT WAS GIVEN ASPIRIN LATER IN THE POST-ANESTHESIA CARE UNIT (PACU), BUT THE PHYSICIAN DECIDED TO STOP ASPIRIN DUE TO THE CATHETER TURNING RED. THE PATIENT WAS ADMITTED TO A HIGHER-LEVEL NURSING UNIT IN STABLE CONDITION. THE PHYSICIAN BELIEVED THAT THIS EVENT WAS UNRELATED TO THE AQUABLATION SURGICAL PROCEDURE AND THE AQUABEAM SYSTEM FUNCTIONED AS EXPECTED. THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL AND IS CURRENTLY DOING WELL.

  Patient problems: Bradycardia; Myocardial Infarction

  MAUDE report 9378295 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) TO REMOVE A CLOT THAT WAS OBSTRUCTING THE FOLEY BALLOON CATHETER POST AN AQUABLATION PROCEDURE. AFTER PLACEMENT, THE FOLEY BALLOON CATHETER ENDED UP IN THE PROSTATE FOSSA RATHER THAN THE BLADDER NECK, WHICH RESULTED IN THE CLOT FORMATION AND REQUIRED REPOSITIONING. CLOT EVACUATION WAS PERFORMED WITH A TOOMEY SYRINGE; NO CAUTERIZATION WAS USED. THE FOLEY BALLOON CATHETER WAS REPOSITIONED IN THE BLADDER NECK. NO FURTHER CLINICAL SEQUELA WAS REPORTED WITH THE PATIENT. THERE WAS NO MALFUNCTION OF THE AQUABEAM SYSTEM OBSERVED DURING THE PROCEDURE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9329863 ↗
• InjuryMay 2, 2018Use of Device Problem; Use of Device Problem

  A MAN UNDERWENT AQUABLATION FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA. PATIENT HAD HISTORY OF RECTAL POLYPS AND DIVERTICULITIS. TWO DAYS AFTER AN UNEVENTFUL AQUABLATION PROCEDURE HE DEVELOPED ABDOMINAL PAIN WITH PERITONEAL SIGNS. ABDOMINAL CT SHOWED FREE AIR IN THE ABDOMEN. HE UNDERWENT LAPAROTOMY DURING WHICH A 1 CM RECTAL PERFORATION IN THE ANTERIOR RECTUM 2 CM BEYOND THE PROSTATE WAS OBSERVED.

  Patient problems: Bowel Perforation

  MAUDE report 7481214 ↗