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

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850055427037), received between Feb 19, 2025 and Jan 5, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (5 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 12 most recent of 12 reports, 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 ↗