MAUDE Adverse Event Report: PROCEPT BioRobotics Corporation AQUABEAM Robotic System; Fluid Jet Removal System

Catalog Number	AB2000
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Laceration(s) (1946); Septic Shock (2068)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Root cause of the reported event has not yet been established.Investigation by manufacturer is currently in process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM Robotic System
• Common Device Name: Fluid Jet Removal System
• Manufacturer (Section D): PROCEPT BioRobotics Corporation; 150 baytech dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BioRobotics Corporation; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; +1(650)232-7291
• MDR Report Key: 50489097
• Report Number: 3012977056-2026-00172
• Device Sequence Number: 13377356
• Product Code: PZP
• UDI-Device Identifier: 00850055427020
• UDI-Public: 0100850055427020112403282124C00774
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: DEN170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male