MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number	AB2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/12/2026
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 became aware that the patient had abdominal distension following aquablation therapy.It was found that the patient had an intraperitoneal bladder rupture.The tear was several centimeters in size, which would not point to an instrument perforation but rather to a pressure-induced perforation.As per the treating surgeon, the potential root cause of this event is a weak spot in the bladder and pressure from the pressure-regulating device (ellik bladder evacuator).The bladder was repaired laparoscopically.The patient has since been discharged and is doing well.No malfunction of the aquabeam robotic system was reported.
Additional Manufacturer Narrative
The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the treatment log files, device history record (dhr), and instructions for use (ifu).The aquabeam robotic system's treatment log files were reviewed, which confirmed no malfunction occurred.The review of the treatment log files revealed that the aquabeam robotic system functioned as intended, as no malfunction was observed during aquablation therapy.A review of the device history record (dhr) for ab2000-b/serial number (b)(6) was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.E, was reviewed.4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: ¿ bladder or prostate capsule perforation the aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.It was reported that the bladder was perforated, which the treating surgeon attributed to a weak spot in the bladder and a pressure-induced perforation from the pressure-regulation device.The treating surgeon does not attribute this event to aquabeam robotic system.The bladder was repaired, and the patient is reported to be doing well.The aquabeam robotic system's ifu lists bladder perforation as potential risk of aquablation therapy.Based on the information obtained through the treating surgeon, plus a review of the treatment log files, dhr, and ifu, the event is considered not to be device-related.No malfunction of the aquabeam robotic system was reported.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 ; 6502327291
• MDR Report Key: 24716678
• Report Number: 3012977056-2026-00056
• Device Sequence Number: 5763697
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20200831D
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/27/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2020
• 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: Required Intervention
• Patient Sex: Male