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	10/13/2025
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 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.
Additional Manufacturer Narrative
The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of aquablation therapy.It was reported that post aquablation, fbnc (focal bladder neck cautery) was initiated and the surgeon experienced difficulty placing the resectoscope into the channel for an extended period of time.Later, the surgeon suspected the patient had a perforated bladder and decided to perform 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.Based on the information received, plus a review of the dhr, and ifu, the event is considered not to be device related.A review of the treatment log files for this procedure could not be conducted as these were not provided.Three good faith efforts (gfe) were made to obtain the log files without success.Shall the log files be made available in the future, then this complaint will be reopened to conduct such a review.A review of the device history record (dhr) for ab2000-d/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 device 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.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: 23319011
• Report Number: 3012977056-2025-00270
• Device Sequence Number: 4838597
• Product Code: PZP
• UDI-Device Identifier: 00850055427020
• UDI-Public: 010085005542702011231214
• 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): 10/16/2025

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: 10/14/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Male