HYDROS Robotic System HY1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00850055427068), received between Jan 7, 2025 and Sep 29, 2026 — classified as 5 deaths, 55 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (20 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 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Visual Prompts will not Clear; Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939043 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Laceration(s)

  MAUDE report 50859573 ↗
• MalfunctionSep 16, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790410 ↗
• MalfunctionSep 16, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790308 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation

  MAUDE report 50722918 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation

  MAUDE report 50566508 ↗
• MalfunctionAug 28, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508236 ↗
• MalfunctionAug 28, 2026Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500956 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A male patient underwent Aquablation therapy for symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics (PROCEPT) became aware that post-Aquablation therapy, the patient experienced postoperative bleeding. The patient received a blood transfusion of one unit. After transfusion, no surgical intervention happened, patient was admitted and discharged the next day. No malfunction of the HYDROS Robotic System was reported.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50098619 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics Corporation (PROCEPT) became aware that, during procedural setup, the patient had a high bladder neck. During insertion of the HYDROS handpiece, the patient experienced a bladder perforation, and a false passage was created as viewed under the cystoscope. After the incident occurred, the surgeon elected to abort the procedure. The surgeon placed an 18Fr (French) catheter into the bladder over a wire. Attempts were made to obtain additional information; however, information could not be retrieved regarding the event and patient status. No malfunction of the HYDROS Robotic System was reported.

  Patient problems: Perforation

  MAUDE report 50094007 ↗
• InjuryMay 14, 2026Adverse 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, FOLLOWING AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND REQUIRED RETURN TO THE OPERATING ROOM. THE SOURCE OF BLEEDING NEEDED TO BE IDENTIFIED; HOWEVER, THE PATIENT NEEDED TO BE RESUSCITATED IN THE OPERATING ROOM DUE TO A LOSS OF BLOOD AND SUBSEQUENT CARDIAC ARREST. IT WAS DETERMINED THAT THE PATIENT'S PROSTATE CAPSULE RUPTURED. THE PATIENT HAD BEEN SCOPED AT THE END OF THE AQUABLATION THERAPY, AND THERE WERE NO SIGNS OF PROSTATE CAPSULE RUPTURE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND RECEIVED ADDITIONAL CAUTERY TO STOP THE BLEEDING. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 25174554 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT'S ABDOMEN WAS DISTENDED. THE TREATING SURGEON HYPOTHESIZED THAT INADVERTENT CONTACT WITH THE CONTRALATERAL BLADDER WALL MAY HAVE OCCURRED DURING REPOSITIONING OF THE HYDROS HANDPIECE WHILE IDENTIFYING THE URETERAL ORIFICES (UO) AND VERUMONTANUM. SUBSEQUENTLY, THE PATIENT EXPERIENCED A BLADDER PERFORATION REQUIRING MEDICAL INTERVENTION. THE SURGEON PERFORMED A CYSTOGRAM UNDER FLUOROSCOPIC GUIDANCE, FOLLOWED BY AN ATTEMPT AT MINIMALLY INVASIVE MANAGEMENT USING THE DA VINCI SURGICAL SYSTEM; HOWEVER, CONVERSION TO AN OPEN PROCEDURE WAS ULTIMATELY NECESSARY. AS OF (B)(6) 2026, THE PATIENT HAS NOT YET BEEN DISCHARGED AND REMAINS ADMITTED DUE TO AN OPEN PROCEDURE. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 25155317 ↗
• DeathMay 12, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT THE PATIENT CODED POST-AQUABLATION THERAPY. THE PATIENT WAS RESUSCITATED AND LEFT THE OPERATING ROOM (OR). THE PATIENT CODED A SECOND TIME, A FEW HOURS LATER, IN THE INTENSIVE CARE UNIT (ICU) AND PASSED AWAY. AS PER THE SURGEON, PULMONARY EMBOLISM CONTRIBUTED TO THE EVENT. THE SURGEON STATED THAT THE OUTCOME WAS NOT RELATED TO AQUABLATION. AQUABLATION THERAPY WAS COMPLETED SUCCESSFULLY. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 25153866 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE, POST-AQUABLATION THERAPY, THAT THE PATIENT HAD A LARGE CLOT ACCUMULATION ANTERIOR TO THE BLADDER NECK. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) FOR CLOT EVACUATION. AFTER THE CLOT WAS REMOVED, MINIMAL RESECTION WAS DONE IN THAT AREA. THE TREATING SURGEON PLACED A CATHETER AND STARTED CONTINUOUS BLADDER IRRIGATION (CBI) AS ROUTINE. NO ARTERIAL BLEEDING WAS NOTED DURING INSPECTION. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25022147 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT POST-AQUABLATION, THE PATIENT EXPERIENCED RECTAL INJURY. IT WAS ALSO NOTED THAT, DESPITE THE PATIENT HAVING A J-POUCH, THE PATIENT UNDERSTOOD THE INHERENT RISKS AND WAS STILL DETERMINED TO UNDERGO AQUABLATION THERAPY. ACCORDING TO THE TREATING SURGEON, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT STATUS AND WHETHER THEY HAVE BEEN DISCHARGED REMAIN UNKNOWN DESPITE MULTIPLE FOLLOW-UPS. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 25018682 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS WAS INFORMED THAT, FOLLOWING AQUABLATION THERAPY AND AS A PRECAUTION, THE PATIENT UNDERWENT A BLOOD TRANSFUSION. IT WAS NOTED THAT THE PATIENT'S HEMOGLOBIN LEVELS DROPPED FROM 11 G/DL TO 8 G/DL AND THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) DECIDED TO ADMINISTER TWO UNITS OF BLOOD. THE PATIENT WAS NOT TAKING ANY BLOOD THINNERS OR ANTICOAGULANTS PRIOR TO AQUABLATION THERAPY. THE PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25017341 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING HEMOSTASIS, THE TREATING SURGEON IDENTIFIED A BLADDER PERFORATION. AS PER THE TREATING SURGEON, IT WAS LIKELY DUE TO THE PATIENT'S OVERDISTENDED BLADDER DURING THE PROCEDURE, BUT THE SURGEON WAS UNSURE WHEN IT HAD OCCURRED. THE BLADDER WAS SURGICALLY REPAIRED, AND THE PATIENT HAS SINCE BEEN DISCHARGED AND IS RECOVERING WELL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 25009864 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, DURING AQUABLATION THERAPY, THE PATIENT EXPERIENCED A BLADDER PERFORATION. THE TREATING SURGEON DETERMINED THAT THE PERFORATION OCCURRED DURING THE PROCEDURE FOLLOWING THE INITIAL PASS, AT WHICH TIME THE PATIENT'S BLADDER WAS OVERDISTENDED, AND THE PATIENT EXHIBITED SUDDEN BUCKING MOVEMENT. THE SURGEON FURTHER STATED THAT IT WAS POTENTIALLY RELATED TO THE ASPIRATION TUBING BEING INSTALLED BACKWARD DURING SETUP. THE SURGEON ALSO DETERMINED THAT NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24985127 ↗
• MalfunctionApr 21, 2026Visual Prompts will not Clear

  A MALE PATIENT WAS SCHEDULED FOR AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE HYDROS ROBOTIC SYSTEM EXPERIENCED A COMMUNICATION ERROR CODE (E480) WITH THE POWER DISTRIBUTION UNIT. THE ERROR COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS. 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 FOR THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945395 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE TREATING SURGEON NOTED A POSSIBLE PERFORATION OF THE BOWEL AFTER REMOVAL OF THE TRUS PROBE. THE CASE WAS CONVERTED TO A DIVERTING COLOSTOMY USING THE DA VINCI SURGICAL SYSTEM. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS ABOUT THIS EVENT; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24912869 ↗
• InjuryApr 15, 2026Adverse 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 DURING AQUABLATION THERAPY, THE PATIENT'S BLADDER NECK WAS UNDERMINED. THE PATIENT'S URETERAL ORIFICES (UOS) WERE INTACT BUT VERY CLOSE TO THE UNDERMINED BLADDER NECK REGION. THE TREATING SURGEON DECIDED TO MOVE FORWARD WITH PLACING PRECAUTIONARY STENTS. THE PATIENT IS RECOVERING NORMALLY AND WILL BE REASSESSED FOR STENT REMOVAL IN ONE MONTH. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 24885377 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT AT THE END OF FOCAL BLADDER NECK CAUTERY, THE TREATING SURGEON IDENTIFIED A BLADDER PERFORATION. THE PERFORATION WAS VIEWED POSTERIOR LATERALLY BEYOND THE URETERAL ORIFICES (UO'S). THE SURGEON DESCRIBED IT AS WHAT LOOKS LIKE A "LACERATION" AND A MUCOSAL TEAR. SOME FAT WAS VISIBLE AS WELL. THE PATIENT DID NOT NEED ANY FURTHER SURGICAL INTERVENTION. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND IS RECOVERING WELL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24877451 ↗
• DeathApr 11, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT DIED ON (B)(6) 2026. IT WAS REPORTED THAT THE PATIENT UNDERWENT BLADDER STONE REMOVAL A FEW DAYS PRIOR TO AQUABLATION THERAPY. ON THE DAY OF THE AQUABLATION PROCEDURE, THE SURGEON PERFORMED FURTHER BLADDER STONE REMOVAL DUE TO RESIDUAL STONES. AFTER COMPLETING THE BLADDER STONE REMOVAL, THE SURGEON THEN PROCEEDED WITH AQUABLATION THERAPY. AQUABLATION THERAPY WAS SUCCESSFUL; HOWEVER, AFTER THE TRANSFER TO THE POST ANESTHESIA CARE UNIT (PACU), THE PATIENT'S CONDITION DETERIORATED, AND THE PATIENT WENT INTO CARDIAC ARREST. ALTHOUGH THE HEALTHCARE TEAM WAS ABLE TO STABILIZE HIM, THE PATIENT HAD A DO-NOT-RESUSCITATE (DNR) ORDER ON FILE. AFTER SEVERAL HOURS OF MANAGEMENT, THE PATIENT PASSED AWAY. IT WAS PREVIOUSLY DOCUMENTED THAT THE SURGEON HAD ASKED THE PATIENT WHETHER A DNR SHOULD BE HONORED IF COMPLICATIONS OCCURRED, AND THE PATIENT STATED THAT HE DID NOT WISH TO BE RESUSCITATED. THE SURGEON DOES NOT BELIEVE THE OUTCOME WAS DIRECTLY RELATED TO THE AQUABLATION PROCEDURE. RATHER, THE SURGEON SUSPECTED THAT THE

  Patient problems: Cardiac Arrest

  MAUDE report 24852943 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT PRESENTED WITH A BLADDER INJURY. THE PATIENT WAS ADMITTED TO A NEIGHBORING HOSPITAL AND CONTINUED ON CONTINUOUS BLADDER IRRIGATION (CBI). THE PATIENT UNDERWENT STANDARD BLADDER IMAGING, AND A FOLEY CATHETER WAS PLACED. MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE INFORMATION ABOUT THE EVENT, BUT NO OTHER DETAILS WERE PROVIDED. IT IS NOT KNOWN AT THIS POINT WHAT CAUSED THE BLADDER INJURY. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 24795563 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS WAS INFORMED THAT, POST AQUABLATION THERAPY, THE PATIENT REQUIRED A BLOOD TRANSFUSION. IT WAS NOTED THAT THE PATIENT WAS NOT TAKING ANY BLOOD THINNERS OR ANTICOAGULANTS PRIOR TO AQUABLATION THERAPY. THE PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24794380 ↗