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

Catalog Number	AB2000
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
The aquabeam scope was returned for investigation.Functional testing was conducted by looking through the eyepiece of the lens.No image could be seen through the eyepiece, indicating an internal fiber optic break.Additionally, scope lens surface was observed under magnification and a crack could be observed, confirming the reported failure.However, cause is undeterminable as it is unclear how the lens and fiber optics got damaged at the hospital.A review of the device history record (dhr) for aquabeam scope lot number 2219 and 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.Aquabeam robotic system user manual sj-um0101-00 rev c section 11.2.6 states the below: verify the aquabeam scope visualization by viewing the image through the camera source port (the eyepiece).If any defect in the image is observed, check the cleanliness of the optical surfaces (distal and proximal lenses).The lens should appear smooth and shiny.Poor cleanliness of exterior surfaces can cause a foggy or cloudy image.Note: obtain a new aquabeam scope if proper visualization cannot be verified.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: 22879811
• Report Number: 3012977056-2025-00226
• Device Sequence Number: 10386799
• Product Code: PZP
• UDI-Device Identifier: 00850055427020
• UDI-Public: 010085005542702011231122
• 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,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male