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 10/03/2023

Event Type  malfunction  

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.

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 procedure the aquabeam robotic system generated multiple "e04 -console error" messages, which had to be cleared throughout the procedure to complete three treatment pass.The reported event caused a surgical procedure delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam console was returned for investigation.Functional testing was able to replicate the e04 error upon priming at 50% and 100% power.E02 and e03 errors were also observed during functional testing.Additional analysis noted oil and debris particulates on the encoder sensor and was identified to be the main cause of the e04 issues.A review of the device history record (dhr) (b)(4) / serial number (b)(6) and aquabeam console / lot number 23c02312 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.The current user manual um0102-00 rev.D, aquabeam robotic system user manual, canada, english was reviewed.Table 5: system detected errors and faults e04 - console error; release foot pedal and click x.If error persists, turn off and turn on console.The root cause of the reported event has been determined to be due to design.The reported issue is being addressed through our quality system.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: 17936337
• MDR Text Key: 325699125
• Report Number: 3012977056-2023-00178
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/16/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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