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 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation was informed that during the aquablation treatment, the aquabeam robotic system encountered an "e22 - motorpack error" during jet alignment.The procedure setup was executed without any issues, and the system was primed successfully.However, upon attempting to align the jet inside the patient by stepping on the pedal, an e-22 error occurred.Despite efforts to clear the error, it was necessary to undock the handpiece and replace it before proceeding.Subsequently, the procedure was successfully completed after the handpiece replacement.The incident resulted in a surgical delay over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation.Investigation into this issue has confirmed the occurrence of "e22 - motorpack" error upon docking and could be cleared.The handpiece was deconstructed and viewed under magnification.No signs of fluid ingress were observed on the sensor board and the encoder wheel.The root cause is undeterminable as the e22 could be cleared.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c01418 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 segregated and reworked to address the non-conformance.The handpiece passed final inspection prior to release for distribution.The current user manual sj-um0101-00 rev.B, um, aquabeam robotic system user manual, us, baytech 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 submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Correction: ab2000-b / serial number 19c01610 and aquabeam handpiece / lot number 23c01418.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c01418 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 segregated and reworked to address the non-conformance.The handpiece passed final inspection prior to release for distribution.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 dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose 95134
• MDR Report Key: 19008761
• MDR Text Key: 339245819
• Report Number: 3012977056-2024-00094
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20191205J
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2023
• 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