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

Model Number	HP2000
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The aquabeam scope was returned for investigation of the reported event.Functional testing of the returned device confirmed the reported event.Examination of the distal tip under magnification showed signs of adhesive degradation and residual fluid inside the lens which was consistent with the functional testing.A review of the device history record (dhr) ab2000-b/ serial number (b)(6) , and aquabeam scope with lot number 72117/s0040 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 current user manual, um0104-00 rev.G aquabeam robotic system user manual, intl (ce), en was reviewed.Section 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup.· 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.The root cause of reported event was determined to be design-relate.The issue has been addressed as a part of procept's quality management system.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 an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure, the aquabeam scope was unable to provide a clear visualization.Multiple troubleshooting steps were made to address the issue without avail.As a result, the surgeon decided to abort the aquablation procedure and converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to this event.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065 ; 6502327291
• MDR Report Key: 17309931
• Report Number: 3012977056-2023-00117
• Device Sequence Number: 7185079
• Product Code: PZP
• UDI-Device Identifier: B614HP20001
• UDI-Public: +B614HP20001/$$721C01646/16D20211014C
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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 Model Number: HP2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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