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

Catalog Number AB2000

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedural setup, upon connecting the aquabeam handpiece and aquabeam motorpack, the aquabeam robotic system generated multiple errors such as "e22 - motorpack error", "e23 - motorpack error", "e31 - motorpack error", and "e42 - motorpack error".Despite multiple troubleshooting attempts, the issue persisted.A second aquabeam handpiece was tried, but the issue persisted.Finally, a third aquabeam handpiece and a second aquabeam motorpack were used, which resolved the issue.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient as a result of this event.

Manufacturer Narrative

Adverse event problem component code 4756: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors.Root cause of 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.

Manufacturer Narrative

H.11 additional manufacturer narrative: the aquabeam handpiece was returned for investigation.No visual defects or anomalies were observed with the handpiece.Functional testing of the handpiece triggered e22 error on docking and could be cleared.A full aquablation simulation could be conducted.Reported failure mode 1 was confirmed, however, the system did not trigger e31.The handpiece was deconstructed and viewed under magnification.Signs of fluid ingress were observed on the encoder wheel.Thus, the root cause was determined to be fluid ingress.However, the source of the fluid remains undeterminable the log file review was able to confirm the reported e23 and e31 errors.A review of the device history record (dhr) for the aquabeam robotic system serial number (b)(6) aquabeam console lot number 21c01106 was conducted, which confirmed that there was one rework that could be potentially related to the reported event.The lot was segregated and affected units were reworked and re-inspected as part of our handpiece final inspection process.Upon re-inspection, the lot met all required specifications and was deemed acceptable to be released for distribution.The aquabeam robotic system user manual, um0101 rev.F, states the following: table 5: system detected errors and faults e22 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

N/a.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: 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: 18848446
• MDR Text Key: 337778426
• Report Number: 3012977056-2024-00056
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20230320D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male