AquaBeam HandpieceRecalls & reported problems across all models

We found 5 models of AquaBeam Handpiece by PROCEPT BioRobotics Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2019 and Jan 5, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AquaBeam Handpiece problems

AquaBeam Handpiece models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AquaBeam Handpiece HP2000

  Fluid jet removal system
  12 reports
• AquaBeam Handpiece HP2000

  Fluid jet removal system
  5 reports
• AquaBeam Handpiece HP2000

  Fluid jet removal system
  2 reports
• AquaBeam Handpiece HP2000

  Fluid jet removal system
  2 reports
• AquaBeam Handpiece 310301

  Fluid Jet Removal System
  1 report

Recent AquaBeam Handpiece adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Defective Component; No Apparent Adverse Event; Patient Device Interaction Problem; Device Contaminated at the User Facility

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, DURING PROCEDURAL SETUP, THE AQUABEAM HANDPIECE BENT DURING INSERTION AS IT ATTEMPTED TO PASS THE BLADDER NECK AND WAS REMOVED. THE HANDPIECE AND STERILE SCOPE WERE SUBSEQUENTLY PLACED ON AN UNSTERILE TRAY. DUE TO A LACK OF ADDITIONAL STERILE SCOPES, THE CASE WAS ABORTED AND RESCHEDULED FOR THE FOLLOWING DAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970287 ↗
• MalfunctionNov 6, 2025Therapeutic or Diagnostic Output Failure

  DURING THE PROCEDURE, THE SURGEON AND THE TECH NOTICED THAT THE AQUABLATION HANDPIECE WAS MALFUNCTIONING. THE REPS WERE PRESENT AND TRIED TO TROUBLESHOOT, TO NO AVAIL. THE DEVICE WAS REPLACED WITH A NEW HANDPIECE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485249 ↗
• MalfunctionJun 4, 2025Firing Problem; Firing Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY, DURING THE JET ALIGNMENT STEP OF THE PROCEDURE, THE WATERJET FAILED TO ACTIVATE WHEN THE SURGEON PRESSED THE FOOT PEDAL. IN RESPONSE, THE SURGEON REMOVED THE HANDPIECE AND ATTEMPTED TO ACTIVATE THE WATERJET AGAIN BY PRESSING THE FOOT PEDAL; HOWEVER, THE WATERJET STILL DID NOT ENGAGE. A NEW HANDPIECE WAS INSTALLED, BUT THE ISSUE PERSISTED. UPON FURTHER TROUBLESHOOTING, THE WATERJET FUNCTIONED AS EXPECTED, AND THE PROCEDURE COULD CONTINUE WITHOUT FURTHER PROBLEMS. 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 22142394 ↗
• MalfunctionJun 4, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT THE AQUABEAM HANDPIECE/ SYSTEM EXPERIENCED TECHNICAL DIFFICULTIES DURING AQUABLATION THERAPY. THE PATIENT PRESENTED WITH URETHRAL STRICTURES, NECESSITATING THE USE OF VAN BUREN SOUNDS TO ACHIEVE DILATION. A RESECTOSCOPE WAS THEN USED FURTHER TO EXPAND THE URETHRA BEFORE THE INSERTION OF THE HANDPIECE. THE SURGEON COMPLETED ALL STANDARD PREPARATIONS AND INITIATED THE PROCEDURE AS EXPECTED. THE HANDPIECE WAS PRIMED AND TESTED, INCLUDING VERIFICATION OF JET FUNCTION DURING SETUP. ONCE THE HANDPIECE WAS INTRODUCED AND THE SYSTEM PROCEEDED TO THE JET ALIGNMENT STAGE, AN E22 - MOTORPACK ERROR WAS TRIGGERED. TROUBLESHOOTING STEPS WERE TAKEN; HOWEVER, THE E22 ERROR PERSISTED; THEREFORE, A NEW HANDPIECE WAS INTRODUCED AND SET UP ACCORDINGLY. THE E22 ERROR DID NOT RECUR; HOWEVER, A NEW ERROR, E50 - CONSOLE ERROR, APPEARED, PROMPTING ADDITIONAL TROUBLESHOOTING, WHICH RESOLVED THE ERROR AND ALLOWED THE PROCEDURE TO CONTINUE AND COMPLETE SUCCESSFULLY. THE REPORTED EVENT CAUSED A SURGICAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142326 ↗
• MalfunctionMay 21, 2025Firing Problem; Firing Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE AQUABEAM HANDPIECE EXPERIENCED WATERJET FAILURE DURING THE ALIGNMENT PROCESS. AFTER TROUBLESHOOTING EFFORTS, IT WAS ULTIMATELY REPLACED WITH A NEW AQUABEAM HANDPIECE. THE PROCEDURE WAS THEN 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 22065282 ↗
• MalfunctionMar 27, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, IT WAS NOTICED THAT THE AQUABEAM SCOPE WAS INITIALLY INSERTED INCORRECTLY INTO THE AQUABEAM HANDPIECE. THIS MISTAKE WAS IDENTIFIED WHEN THE CAMERA WAS CONNECTED TO THE SCOPE BEFORE HANDPIECE INSERTION INTO THE PATIENT. THE SURGEON WAS THEN GUIDED THROUGH PROPERLY RE-INSERTING THE SCOPE INTO THE HANDPIECE. AFTER THIS CORRECTION, THE CASE PROCEEDED AS PLANNED. HOWEVER, DURING THE FINAL 10 SECONDS OF THE FIRST TREATMENT PASS, AN ERROR CODE"E22 - MOTORPACK ERROR" APPEARED AND COULD NOT BE CLEARED. GIVEN THE CIRCUMSTANCES, THE SURGEON DECIDED THAT ONE TREATMENT PASS WAS SUFFICIENT FOR THE PATIENT AND CHOSE NOT TO SWAP THE HANDPIECE. THE SURGEON ENDED UP RESECTING SOME ADDITIONAL TISSUE AFTER THE SINGLE-PASS AQUABLATION PROCEDURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709906 ↗
• MalfunctionMar 19, 2025Failure to Align; Failure to Align

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION WAS NOTIFIED OF AN ISSUE DURING PROCEDURAL SETUP, WHILE THE PATIENT WAS UNDER ANESTHESIA IN THE OPERATING ROOM, WHERE THE AQUABEAM HANDPIECE EXPERIENCED JET ALIGNMENT DIFFICULTIES. IN RESPONSE, THE TREATING SURGEON OPTED TO REPLACE THE HANDPIECE WITH A NEW ONE, ALLOWING THE PROCEDURE TO BE SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS. 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 21646375 ↗
• MalfunctionMar 17, 2025Mechanical Problem; Failure to Align; Mechanical Problem; Failure to Align

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING PROCEDURAL SET UP, THE AQUABEAM SCOPE COULD NOT BE LOCKED INTO THE AQUABEAM HANDPIECE. A SECOND HANDPIECE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE REPORTED EVENT CAUSED A PROCEDURAL DELAY OF OVER 20 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625849 ↗
• MalfunctionMar 13, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY, TWO HANDPIECES OF THE AQUABEAM ROBOTIC SYSTEM EXPERIENCED INCOMPLETE WATER JET CALIBRATION, IN CONJUNCTION WITH REPEATED ERRORS: 'E22 - MOTORPACK ERROR' AND 'E50 - CONSOLE ERROR.' DESPITE EFFORTS, THESE ERRORS COULD NOT BE CLEARED. A THIRD HANDPIECE WAS OPENED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. 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 21598998 ↗
• MalfunctionMar 10, 2025Firing Problem; Firing Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING PROCEDURAL SETUP, THE AQUABEAM HANDPIECE EXPERIENCED AN ISSUE WITH JET ALIGNMENT. UPON REPLACING THE HANDPIECE, THE SURGEON PROCEEDED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS EVENT RESULTED IN 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 21561988 ↗
• MalfunctionFeb 26, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE HANDPIECE OF THE AQUABEAM ROBOTIC SYSTEM ENCOUNTERED AN 'E22 - MOTORPACK ERROR, R POSITION LOST' DURING THE PROCEDURE. DESPITE THE SURGEON'S EFFORTS TO TROUBLESHOOT THE ISSUE, THE ERROR COULD NOT BE RESOLVED. AS A RESULT, AN ALTERNATIVE HANDPIECE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 21471202 ↗
• MalfunctionFeb 19, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING PROCEDURAL SETUP, THE AQUABEAM ROBOTIC SYSTEM GENERATED CODES: "E23 - MOTORPACK ERROR R POSITION LOST" AND "E21 - MOTORPACK ERROR R MOTOR SIGNAL LOST". DESPITE THE ERRORS, THE TREATING SURGEON WAS ABLE TO COMPLETE THE CASE. 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 21413350 ↗
• 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 ↗
• 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 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 ↗

Other PROCEPT BioRobotics Corporation products

• AquaBeam Robotic System3 models · 944 reports