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

Catalog Number AB2000

Device Problems Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that during the aquablation procedural set-up, while priming the aquabeam handpiece, the aquabeam robotic system generated an "e02 - console error" message.Multiple troubleshooting attempts were made with no success.As a result, the aquablation procedure was aborted.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

Component code = 4756 - aquabeam console, a reusable component of the aquabeam robotic system, controls the functionality of the high-velocity waterjet delivered by the aquabeam handpiece.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

The aquabeam console was returned for investigation.No visual defects or anomalies were observed.Functional testing confirmed the reported event.Upon further testing, a layer of oil was observed on the encoder lens and sensor, which could potentially cause the reported e02/e03 errors.The root cause of the reported event was determined to be design-related.The issue has been addressed as part of procept's quality management system.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam console / lot number 22c04474 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 failure.The review indicated that the device met all design and manufacturing specifications when released for distribution.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.Table 5 system detected errors and faults e02 - console error release foot pedal and click x.If error persists, turn off and turn on console.E03 - console error release foot pedal and click x.If error persists, turn off and turn on console.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: 18164690
• MDR Text Key: 328969068
• Report Number: 3012977056-2023-00222
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221122C
• 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: 02/02/2024

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: 11/03/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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