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	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is currently in-process; root cause has not yet been established by the manufacturer.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, and while priming the aquabeam handpiece, an "e05 - console error" message was generated by the aquabeam robotic system.After multiple troubleshooting steps were performed, the procedure was able to be continued through successful completion.The reported event caused a procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the reported event.
Additional Manufacturer Narrative
H10 additional manufacturer narrative: the aquabeam handpiece was not returned for investigation.The investigation of this event is based on a review of log files, device history record, labeling, and similar complaint review.A review of the aquabeam robotic system log file confirmed the reported "e05: console error" message due to transient clogging observed in the handpiece.A review of the device history record (dhr) for ab2000/serial number (b)(6) and aquabeam handpiece/lot number 21c01647 was performed, which confirmed that there were no nonconformances, 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.A review of similar complaints confirmed five (5) other similar events have been reported to procept.The aquabeam robotic system user manual, um0101-00 rev.F, was reviewed and states the following: e05: console error; release foot pedal and replace handpiece; then turn off and turn on console.The handpiece was not returned for investigation; therefore, it was not possible to determine how the handpiece was clogged.The root cause remains undeterminable.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; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 13660207
• Report Number: 3012977056-2022-00019
• Device Sequence Number: 1944664
• Product Code: PZP
• UDI-Device Identifier: B614HP20001
• UDI-Public: +B614HP20001/$$721C01647/14D20231130Z
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2021
• 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