HYDROS Handpiece HH1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850055427051), received between Feb 18, 2025 and May 26, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (8 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 18, 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.

• MalfunctionMay 26, 2026Visual 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, THE HYDROS ROBOTIC SYSTEM THREW AN E917 CYSTOSCOPE SENSOR TIP DISCONNECTED ERROR MESSAGE. DUE TO THE DELAY AND THE PATIENT'S SMALL PROSTATE GLAND THE TREATING SURGEON ELECTED TO PROCEED WITH A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) INSTEAD. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283023 ↗
• MalfunctionMar 26, 2026Visual Prompts will not Clear

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING THE FIRST TREATMENT PASS, THE HYDROS ROBOTIC SYSTEM DISPLAYED ERROR E251 (Z ENCODER SPEED WAS LESS THAN 80% OF THE DESIRED SPEED FOR OVER 10MS). THE TREATING SURGEON TRIED TO MANUALLY MOVE THE WATERJET, BUT THE ERROR PERSISTED. DUE TO THE INABILITY TO RESOLVE THE ISSUE, THE TREATING SURGEON DECIDED TO ABORT THE PROCEDURE. 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 24701228 ↗
• MalfunctionJan 26, 2026

  JUST AS DOCTOR WAS ABOUT TO DO THE CALIBRATION OF THE AQUABLATION HAND PIECE WE REALIZED THAT THE DEVICE WAS SHOWING BLANK ON THE SCREEN. THIS WAS WHEN THE DEVICE WAS STILL IN THE PATIENT'S URETHRA. DEVICE WAS REPLACED WITH ANOTHER ONE AND MED WATCH REPORT WAS MADE. NO PATIENT SAFETY CONCERN AND NO GENERAL SAFETY CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177206 ↗
• MalfunctionJan 26, 2026

  JUST AS DOCTOR WAS ABOUT TO DO THE CALIBRATION OF THE AQUABLATION HAND PIECE WE REALIZED THAT THE DEVICE WAS SHOWING BLANK ON THE SCREEN. THIS WAS WHEN THE DEVICE WAS STILL IN THE PATIENT'S URETHRA. DEVICE WAS REPLACED WITH ANOTHER ONE AND MED WATCH REPORT WAS MADE. NO PATIENT SAFETY CONCERN AND NO GENERAL SAFETY CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177069 ↗
• MalfunctionDec 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION WAS NOTIFIED THAT AFTER AQUABEAM HANDPIECE INSERTION, THE CUSTOMER HEARD A CRACKING SOUND AND RECEIVED AN UNSPECIFIED ERROR CODE. THE HANDPIECE WAS REMOVED AND OBSERVED TO BE SLIGHTLY BENT. A NEW HANDPIECE WAS ATTACHED AND INSERTED, BUT THERE WAS RESISTANCE WHEN SCROLLING THE SCOPE TIP, AND THE CYSTOSCOPE IMAGE NO LONGER WORKED. AS A RESULT OF THIS EVENT, THE SURGEON ELECTED TO PROCEED WITH A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) INSTEAD. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790795 ↗
• MalfunctionSep 8, 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 WAS NOTIFIED THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OR UNDER ANESTHESIA, AN ERROR "E917 CYSTOSCOPE SENSOR TIP DISCONNECTED" OCCURRED DURING ANGLE PLANNING. TROUBLESHOOTING STEPS WERE INITIATED, THE CUSTOMER ATTEMPTED TO CLEAR THE ERROR MESSAGE, RESEAT THE CYSTOSCOPE CORD, AND REBOOT THE HYDROS ROBOTIC SYSTEM, BUT THE ISSUE PERSISTED. AS A RESULT OF THE PROBLEM, THE TREATING SURGEON CONVERTED THE PROCEDURE TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE PATIENT WAS DISCHARGED THE NEXT DAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994239 ↗
• 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 DURING THE AQUABLATION THERAPY PROCEDURE, THE HYDROS ROBOTIC SYSTEM GENERATED AN "E560 - PCIE NOT PRESENT" ERROR. THE OPERATING SURGEON ATTEMPTED TO RESOLVE THE ISSUE, BUT THE ERROR PERSISTED. CONCURRENTLY, THE CYSTOSCOPE EXHIBITED VISUAL DISTORTIONS AS WELL. THE SURGEON PERFORMED MULTIPLE TROUBLESHOOTING STEPS IN RESPONSE, BUT THE PROBLEM REMAINED UNRESOLVED. ULTIMATELY, THE HYDROS HANDPIECE WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER INCIDENT. 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 22142765 ↗
• MalfunctionMay 28, 2025Failure to Prime; Power Problem; Failure to Prime; Power Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING SETUP, THE HYDROS ROBOTIC SYSTEM WAS INADVERTENTLY UNPLUGGED DURING THE INSERTION OF THE HYDROS HANDPIECE, RESULTING IN AN UNEXPECTED SYSTEM SHUTDOWN. AFTER RESTORING POWER, THE SYSTEM PROMPTED THE SURGEON TO PRIME THE HYDROS HANDPIECE. HOWEVER, ACTIVATION OF THE PRIME FUNCTION VIA THE HYDROS FOOT PEDAL YIELDED NO RESPONSE. TROUBLESHOOTING STEPS WERE TAKEN, BUT THE ISSUE PERSISTED. SUBSEQUENTLY, THE HANDPIECE WAS REPLACED WITH A NEW UNIT, AND THE SYSTEM WAS REBOOTED. THIS RESOLVED THE PROBLEM, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 22101135 ↗
• MalfunctionMar 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 WAS INFORMED OF AN INCIDENT DURING AQUABLATION THERAPY WHILE THE PATIENT WAS UNDER ANESTHESIA IN THE OPERATING ROOM, IN WHICH THE HANDPIECE OF THE HYDROS ROBOTIC SYSTEM GENERATED AN UNSPECIFIED ERROR CODE RELATED TO THE CYSTOSCOPE. IN RESPONSE TO THIS ERROR, THE TREATING SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) IN ORDER TO COMPLETE THE TREATMENT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646327 ↗
• 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 WAS NOTIFIED THAT DURING AN AQUABLATION THERAPY PROCEDURE, THE HYDROS ROBOTIC SYSTEM ENCOUNTERED AN 'E900 SOFTWARE FAULT' ERROR CODE. DESPITE EFFORTS, THE ERROR COULD NOT BE CLEARED. AS A RESULT, THE TREATING SURGEON MADE THE DECISION TO ABORT THE PROCEDURE AND PROCEED WITH A 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 21599025 ↗
• MalfunctionFeb 24, 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 ON THE HYDROS ROBOTIC SYSTEM GENERATED ERROR CODE ¿E917 ¿ CYSTOSCOPE SENSOR TIP DISCONNECTED¿. THE SURGEON OPTED TO SWITCH TO AN ALTERNATE HANDPIECE FOR THE HYDROS ROBOTIC SYSTEM; HOWEVER, THE SAME ERROR CODE PERSISTED. A THIRD HANDPIECE WAS SUBSEQUENTLY OPENED AND USED, ALLOWING THE PROCEDURE TO BE COMPLETED 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 21453861 ↗
• MalfunctionFeb 18, 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 (PROCEPT) BECAME AWARE THAT DURING PROCEDURAL SETUP, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E827 - MONITOR TOUCH SCREEN IS NOT AVAILABLE" WHICH WAS UNABLE TO BE CLEARED. THE TREATING SURGEON DECIDED TO ABORT THE PROCEDURE DUE TO THE E827 ERROR ISSUE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404960 ↗