AquaBeam Robotic System AB2000 (REF AB2000-D, AB2000-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00850055427020), received between Mar 6, 2024 and Aug 28, 2026 — classified as 5 deaths, 59 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (26 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Infusion or Flow Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics Corporation (PROCEPT) became aware that the patient developed sepsis, requiring medical intervention. It was reported that during the second treatment pass of Aquablation, the aspiration tube became clogged on the AQUABEAM Handpiece, and the surgeon elected to convert the procedure to transurethral resection of the prostate (TURP). Additional information obtained indicated that the patient's bladder wall was injured during the Aquablation procedure, but no perforation was observed. As a result of the sepsis, the patient was transferred to the intensive care unit (ICU) for treatment, then transferred to the urology ward, and eventually recovered. The exact cause of the sepsis remains unknown.

  Patient problems: Laceration(s); Septic Shock

  MAUDE report 50489097 ↗
• InjuryJul 31, 2026Computer Software Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH). PROCEPT BioRobotics Corporation became aware that, post-Aquablation therapy, during Focal Bladder Neck Cautery (FBNC), it appeared that no butterfly cut was performed even though the treating surgeon adequately planned the treatment on the Aquabeam Robotic System. The system indicated a right apical cut followed by a left apical cut, but the butterfly cut could not be visualized on the cystoscope, indicating that the patient's veru-protection zone was ablated with the waterjet. The patient did not receive any additional medical intervention.

  Patient problems: Sexual Dysfunction

  MAUDE report 50099888 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A male patient underwent Aquablation therapy to treat symptomatic benign prostatic hyperplasia (BPH) on (b)(6) 2026. PROCEPT BioRobotics became aware on (b)(6) 2026 that the patient sustained a slight bladder perforation. The patient had a catheter in place before Aquablation therapy and a pre-existing diverticulum. It was also noted that the patient had lots of calcifications that potentially distorted the ultrasound image, and cautery took an extended time due to an erection and leftover apical tissue. The patient was then sent home, but later fell ill, and a CT scan revealed leakage in the bladder. The treating surgeon is unsure of the origin of the leakage and has no other information. No additional surgery or medical intervention was required. No malfunction of the AQUABEAM Robotic System was reported.

  Patient problems: Perforation

  MAUDE report 50098621 ↗
• 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, POST-AQUABLATION THERAPY, THE PATIENT RETURNED TO THE OPERATING ROOM FOR ADDITIONAL CAUTERY TO CONTROL BLEEDING. THE PATIENT HAS SINCE RECOVERED AND BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24999725 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT THE PATIENT REPORTED SIGNIFICANT ABDOMINAL PAIN POST AQUABLATION THERAPY. A COMPUTED TOMOGRAPHY (CT) IMAGING WAS PERFORMED, WHICH INDICATED A PROSTATE CAPSULE PERFORATION RESULTING IN A SMALL AMOUNT OF FLUID COLLECTION AROUND THE KIDNEYS. PATIENT WAS REPORTED TO BE STABLE AND BEING TREATED WITH ANTIBIOTICS. THE PATIENT DID NOT RECEIVE ANY ADDITIONAL SURGICAL INTERVENTION. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION PROCEDURE OR THE DEVICE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24915257 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT WAS BEING EXTUBATED AND AWAKENED FROM ANESTHESIA AND WENT INTO RESPIRATORY ARREST. THE PATIENT HAD MUCUS SUCTIONED OUT AND WAS RE-INTUBATED. IT WAS NOTED THAT THE PATIENT HAD A LARGE AMOUNT OF MUCUS PRIOR TO THE PROCEDURE. THEY PLACED THE PATIENT ON A VENTILATOR AND MOVED THEM TO THE POST-ANESTHESIA CARE UNIT (PACU). THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Respiratory Arrest

  MAUDE report 24912919 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS INC. (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT EXPERIENCED A SEIZURE IN THE POST ANESTHESIA CARE UNIT (PACU). ACCORDING TO THE TREATING SURGEON, HE BELIEVES THE EVENT IS ATTRIBUTED TO AQUABLATION. THE PATIENT HAD NO PRE-EXISTING CONDITIONS. AFTER THE PATIENT EXPERIENCED A SEIZURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT HAD A PROLONGED HOSPITAL STAY FOR TWO ADDITIONAL DAYS. THE PATIENT HAS BEEN DISCHARGED SINCE THEN. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Convulsion/Seizure

  MAUDE report 24847100 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS INC. (PROCEPT) BECAME AWARE THAT, DURING ROUTINE FOLLOW-UP, THE PATIENT PRESENTED WITH URINARY RETENTION THE DAY AFTER AQUABLATION THERAPY. IT WAS DETERMINED THAT A RESIDUAL FLAP OF TISSUE FROM THE MEDIAN LOBE REMAINED. THE SURGEON CONCLUDED THAT GREATER PRESERVATION OF THE MEDIAN LOBE DURING FOCAL BLADDER NECK CAUTERY (FBNC) WOULD HAVE BEEN APPROPRIATE. THUS, THE URINARY RETENTION WAS NOT DIRECTLY ATTRIBUTABLE TO AQUABLATION, BUT RATHER INADEQUATE HEMOSTASIS RESECTION. A BRIEF TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) WAS GIVEN TO REMOVE THE REMAINING MEDIAN LOBE TISSUE. PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 24840604 ↗
• InjuryApr 8, 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, FOLLOWING AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND REQUIRED RETURN TO THE OPERATING ROOM FOR CLOT EVACUATION. THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24815928 ↗
• InjuryMar 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 WAS INFORMED THAT, POST-AQUABLATION THERAPY, THE PATIENT HAD A BLADDER PERFORATION. THE PATIENT WAS CONVERTED TO OPEN SURGERY VIA A MIDLINE INCISION FOR THE REPAIR OF THE BLADDER PERFORATION. THE SURGEON AND THE SURGEONS WHO CAME IN TO ASSIST WITH THE OPEN REPAIR EXPLAINED THAT THEY BELIEVED THE PERFORATION RESULTED FROM THE IRRIGATION PRESSURE BEING TOO HIGH FOR TOO LONG, WHICH CAUSED THE BLADDER TO EXPAND AND PERFORATE AT THE MIDLINE. THE SURGEON STATED THAT THE REPAIR WAS SUCCESSFUL AND THAT THE PATIENT WAS DOING WELL DESPITE THE PERFORATION. IT WAS REPORTED THAT THE PATIENT HAS SINCE BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24719700 ↗
• InjuryMar 26, 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, FOLLOWING AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND REQUIRED RETURN TO THE OPERATING ROOM FOR CLOT EVACUATION. THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24701237 ↗
• InjuryMar 9, 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 THE PATIENT SUSTAINED A BLADDER PERFORATION. IT WAS NOTED THAT THE CAUSE OF THE PERFORATION IS UNKNOWN AND MAY LIKELY BE ATTRIBUTED TO OVERDISTENTION OR A DIVERTICULUM. A CATHETER WAS INSERTED, AND THE TREATING SURGEON NOTED THAT THE PERFORATION WOULD HEAL WITH CONSERVATIVE MANAGEMENT. NO INTERVENTIONS OR SURGERIES WERE PERFORMED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 24553654 ↗
• InjuryMar 2, 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 FELL IN THE POST-ANESTHESIA CARE UNIT (PACU). IT WAS NOTED THAT THE PATIENT'S CATHETER DARKENED, AND HEMOGLOBIN LEVELS DROPPED. THE PATIENT WAS THEN TRANSFUSED AND STAYED IN THE HOSPITAL FOR AN EXTENDED TIME. THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24491294 ↗
• InjuryFeb 3, 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 THE PATIENT'S BLADDER NECK WAS UNDERMINED WITH RESECTION INTO THE BLADDER. THE PATIENT HAD A HIGH BLADDER FLOOR AND NECK, CONTRIBUTING TO THE DIFFICULTY OF THE CASE. A POST-OP COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, WHICH CONFIRMED THERE WAS NO PERFORATION OF THE BLADDER. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO PLACE A SUPRAPUBIC TUBE. THE PATIENT IS DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 24253306 ↗
• InjuryJan 7, 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 THE SECOND TREATMENT PASS, THE PATIENT HAD A CARDIAC ARREST. A CODE BLUE WAS CALLED TO STABILIZE THE PATIENT. THE TREATING SURGEON SUCCESSFULLY ACHIEVED HEMOSTASIS. IT WAS DETERMINED THAT THE PATIENT HAD A PULMONARY EMBOLISM. THE PATIENT WAS THEN TAKEN TO THE INTENSIVE CARE UNIT (ICU) AS A RESULT OF THIS EVENT. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 23994681 ↗
• MalfunctionDec 5, 2025Firing Problem; Firing Problem

  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 UNDER ANESTHESIA IN THE OPERATING ROOM, THE AQUABEAM HANDPIECE EXPERIENCED JET-FIRING ISSUES. IN RESPONSE TO THE MALFUNCTION, THE TREATING SURGEON OPTED TO SWITCH TO 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 23734724 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION WAS INFORMED THAT THE PATIENT INITIALLY PRESENTED WITH BLADDER STONES, WHICH WERE REMOVED PRIOR TO PROCEEDING WITH AQUABLATION. DURING THE AQUABLATION THERAPY, THE SURGEON IDENTIFIED A HIGH BLADDER NECK. FOLLOWING AQUABLATION, FBNC (FOCAL BLADDER NECK CAUTERY) WAS INITIATED, AND THE SURGEON EXPERIENCED DIFFICULTY PLACING THE RESECTOSCOPE INTO THE CHANNEL FOR AN EXTENDED PERIOD. LATER, THE SURGEON SUSPECTED THE PATIENT HAD A PERFORATED BLADDER AND DECIDED TO PERFORM AN OPEN LAPAROTOMY TO RESOLVE THE PERFORATION. THE TREATING SURGEON SUSPECTS THAT THE RESECTOSCOPE INSERTION LIKELY CAUSED THE PERFORATION. HE DOES NOT ATTRIBUTE IT TO AQUABLATION THERAPY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Perforation

  MAUDE report 23319011 ↗
• InjuryOct 16, 2025Adverse 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 (PROCEPT) BECAME AWARE THAT DURING HEMOSTASIS, THE TREATING SURGEON INADVERTENTLY CUT THE PATIENT¿S URETERAL ORIFICES WITH THE LOOP. AS A RESULT, THE SURGEON PLACED URETERAL STENTS IN BOTH OF THE PATIENT'S URETERAL ORIFICES. THE PATIENT HAS BEEN DISCHARGED AND WILL RETURN FOR STENT REMOVAL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 23315168 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT MODERATE BLEEDING WAS ENCOUNTERED DURING THE PROCEDURE, AND HEMOSTASIS WAS CHALLENGING TO ACHIEVE DUE TO A BROAD PROSTATIC FOSSA. ESTIMATED BLOOD LOSS WAS APPROXIMATELY 3,000 ML. A 22CH THREE-WAY CATHETER (60 ML BALLOON) WAS PLACED POSTOPERATIVELY, BUT DISLODGED DUE TO THE WIDE PROSTATIC CAVITY, LEADING TO CATHETER BLOCKAGE, ACUTE URINARY RETENTION, AND BLADDER OVERDISTENSION FROM IRRIGATION FLUID. THIS WAS PROMPTLY MANAGED BY REPLACING IT WITH A 24CH THREE-WAY CATHETER (60 ML BALLOON) AND SECURED WITH SUPRAPUBIC FIXATION. HEMOSTASIS WAS SUBSEQUENTLY ACHIEVED. THE PATIENT RECEIVED INTRAOPERATIVE TRANSFUSIONS (PACKED RED BLOOD CELLS, CRYOPRECIPITATE, AND FRESH FROZEN PLASMA) AND METARAMINOL INFUSION TO SUPPORT BLOOD PRESSURE. THE PATIENT WAS EXTUBATED POSTOPERATIVELY AND TRANSFERRED TO THE ICU. HEMODYNAMICS STABILIZED OVERNIGHT, IRRIGATION WAS STOPPED AT 24 HOURS, AND THE PATIENT STEPPED DOWN TO THE WARD ON POST-OP DAY ONE. THE CATHETER WAS REMOVED ON POST-OP DAY THREE WITHOUT FURTHER COMPLICATIONS. IT WAS ALSO NOTED THAT THE PATIENT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 23000227 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT WAS REQUIRED TO RETURN TO THE OPERATING ROOM POST-OPERATIVELY FOR CLOT REMOVAL. THERE WAS A BLOOD CLOT EVACUATED, AND A SMALL AMOUNT OF CAUTERY WAS DONE. THE PATIENT HAS BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22994196 ↗
• MalfunctionAug 22, 2025Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE PRIOR TO THE PROCEDURE AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THAT A CRACK WAS DISCOVERED IN THE AQUABEAM SCOPE, RESULTING IN POOR VISIBILITY. THERE WAS NO REPLACEMENT SCOPE AVAILABLE, AND THEREBY THE CASE WAS ABORTED AND RESCHEDULED TO A LATER DATE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879811 ↗
• MalfunctionJul 22, 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 CONSOLE DISPLAYED AN "E03 - CONSOLE ERROR" CODE. TWO AQUABEAM HANDPIECES WERE USED FOR TROUBLESHOOTING, CONFIRMING THE ISSUE WAS WITH THE CONSOLE. DUE TO THE MALFUNCTION, THE SURGEON CONVERTED THE PROCEDURE TO 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 22569983 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT MORE THAN 6 MONTHS POST-AQUABLATION THERAPY, THE PATIENT IS EXPERIENCING ERECTILE DYSFUNCTION AND PEYRONIE'S DISEASE. THE TREATING SURGEON DECLINED TO PROVIDE FURTHER DETAILS ON THIS EVENT. PROCEPT HAS NOT BEEN ABLE TO ESTABLISH THE RELATIONSHIP BETWEEN OUR DEVICE AND THE REPORTED CONDITIONS. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Erectile Dysfunction

  MAUDE report 22546262 ↗
• MalfunctionJul 15, 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 SETUP OF THE AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE AQUABEAM ROBOTIC SYSTEM GENERATED E21 - MOTORPACK ERROR AND E22 - MOTORPACK ERROR. EVENTUALLY, THE PROBLEM WAS RESOLVED BY REPLACING A NEW AQUABEAM HANDPIECE, AND THE AQUABLATION THERAPY WAS COMPLETED SUCCESSFULLY. THE REPORTED EVENT CAUSED A SURGICAL DELAY OF OVER 20 MINUTES. 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 22516098 ↗
• MalfunctionJul 14, 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 SETUP OF THE AQUABLATION PROCEDURE AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN ¿E22 ¿ MOTORPACK ERROR¿. A SECOND AQUABEAM HANDPIECE WAS USED; HOWEVER, THE ERROR PERSISTED. A THIRD AQUABEAM HANDPIECE WAS USED, WHICH RESOLVED THE ERROR, AND AQUABLATION THERAPY WAS COMPLETED. THE REPORTED EVENT CAUSED A SURGICAL DELAY OF OVER 60 MINUTES. 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 22495617 ↗