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

Catalog Number AB2000

Device Problem Break (1069)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the procedure the aquabeam trus stepper on the aquabeam trus articulation arm broke unintentionally as the bedrail was being lowered by the hospital staff to reposition the patient.Attempts to fix the aquabeam trus stepper were unsuccessful and as a result, the aquablation procedure was aborted.A replacement aquabeam trus stepper was obtained later in the day, and the patient was placed under anesthesia again to complete the aquablation procedure.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

H.6 adverse event problem.Component code - 4756, appropriate term/code not available: trus stepper, a reusable component of the aquabeam robotic system, allows the user to advance, retract, rotate, and maintain the position of the trus probe throughout the aquablation procedure.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.

Manufacturer Narrative

H:10 - the information submitted previously was incorrect and irrelevant to this case.The corrected information is provided below.Three (3) good faith attempts were made to retrieve the device; however, the trus stepper was not returned for investigation.The root cause of the reported event could not be established as the trus stepper was not returned for investigation.A review of the device history record (dhr) ab2000-b / 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 system met all design and manufacturing specifications when released for distribution.A review of device history record (dhr) could not be performed as the lot number of the trus stepper was not provided.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.4.2 warnings: procedure setup -ensure the handpiece articulating arm and the trus articulating arm are securely mounted to the surgical table bedrail to prevent unanticipated movement during the aquablation procedure.Section 11.2.8 - attach the trus stepper to the trus articulating arm and advance the trus stepper all the way forward.Level the trus probe receptacle.Submission of this report does not constitue an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation.Visual inspection of the returned device revealed no physical damage or anomalies.Functional testing of the device was able to reproduce the "e22 - motorpack error," but it was subsequently cleared, and attempts to reproduce it were unsuccessful.The handpiece was then deconstructed and observed under magnification, revealing signs of fluid ingress in the form of salt deposits on one of the r-optical sensors.This could potentially be one of the triggers for the e22 error that couldn't be cleared during the treatment phase of the procedure.As the saline dried out, it removed the short circuit and restored functionality within the handpiece.The exact cause of how the e22 error was triggered remains undeterminable, as the e22 that was triggered was found to be transient.The aquabeam robotic system's treatment logs file was reviewed, which confirmed the reported event.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number lot23c02977 was conducted, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.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.E05 - console error.Release foot pedal and replace handpiece.Then turn off and turn on console.Submission of this report does not constitue an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18031097
• MDR Text Key: 326973702
• Report Number: 3012977056-2023-00183
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Public: +B614AB20001/16D20220111+
• 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,Followup
• Report Date: 12/18/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 12/06/2023
• Supplement Dates FDA Received: 12/06/2023; 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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