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	05/08/2026
Type of Reportable Event	Serious Injury
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 device history record (dhr), treatment log files and instructions for use (ifu).A review of the device history record (dhr) for ab2000/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 treatment log file was reviewed, which confirmed no malfunctions during the aquablation procedure and indicated that the system functioned as designed.The aquabeam robotic system's instruction for use (ifu), sj-ifu0104-00, rev.B, 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 in the user facility's possession.It was reported 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.The patient is being managed by catheter and cystogram and has been discharged.No additional surgery or medical intervention was required.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of aquablation therapy.Based on the information received and a review of the treatment log files, dhr, and ifu, the event is considered not device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
Event or Problem Description
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.

• 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: 50098621
• Report Number: 3012977056-2026-00155
• Device Sequence Number: 10271338
• Product Code: PZP
• UDI-Device Identifier: 00850055427020
• UDI-Public: 0100850055427020112405312124C01594
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/31/2026

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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