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 02/13/2024

Event Type  malfunction  

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 Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during procedural setup, the aquabeam robotic system generated an "e22 - motorpack error".Multiple troubleshooting steps were performed; however, the issue persisted.A second aquabeam handpiece was used; however, the issue continued to persist.A third aquabeam handpiece was 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 due to this event.

Manufacturer Narrative

The aquabeam handpieces were returned for investigation.Investigation into this issue has confirmed the occurrence of "e22 - motorpack" errors.The issue is being addressed through procept's quality system.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c11055 was conducted, which confirmed that there were two (2) 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 segregated and reworked to address the non-conformance.The handpiece passed final inspection prior to release for distribution.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed and states: 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.

• 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: 18845867
• MDR Text Key: 336993196
• Report Number: 3012977056-2024-00049
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220810H
• 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: 04/01/2024

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
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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