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

Catalog Number AB2000

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/11/2023

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 the aquablation therapy, the aquabeam handpiece high-velocity waterjet resected the prostatic tissue abnormally deeper than the originally planned resection angles by the treating surgeon.The procedure was able to be completed successfully and there were no adverse health consequences to the patient due to this event.The same event was observed with three (3) patients on the same day (refer to mfr.# 3012977056-2023-00185 and mfr.# 3012977056-2023-00189).

Manufacturer Narrative

H.3 device evaluation by manufacturer: the aquabeam handpiece was returned for investigation.The handpiece was observed to be damaged as the aspiration tube was separated from the manifold and adhesive cracking was seen.Three (3) docking cycles and a full simulated aquablation session were successfully performed.Pressure was applied onto the aspiration tube as part of the simulated aquablation to replicate the handpiece being inside a patient.Due to the aspiration tube separating from the manifold, the aspiration tube was seen to be extended and abnormally bent which could have contributed to "deeper cuts" per the event description.It is probable that stress on the extended aspiration tube caused the jet probe to be positioned at an irregular angle closer to the prostatic tissue and caused the jetting to cut deep.However, it is unknown if this is attributed to the reported failure of inadequate jetting and it could not be confirmed.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c03114 was conducted, which confirmed that there were one (1) non-conformance during the manufacturing process that could be related to the reported event.The lot was segregated and affected units were reworked and re-inspected as part of our handpiece final inspection process.Upon re-inspection, the lot met all required specifications and was deemed acceptable to be released for distribution.The current instruction for use ifu0101-00 rev.E, aquabeam robotic system ifu, us, english was reviewed.8.30 sterile: treatment a.To begin the aquablation treatment, step on the foot pedal and gently support the beige braided tubing extending from the back of the aquabeam handpiece.Caution (for system models other than ab2000c): failure to support the beige braided tubing may result in a system fault or insufficient cutting efficacy.A.During the aquablation treatment, use [-] indicator on the motorpack to decrease power/resection depth (if needed) and use [+] to increase back to planned power 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 CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr.; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18035707
• MDR Text Key: 327758566
• Report Number: 3012977056-2023-00188
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221128M
• 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: 01/26/2024

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: Not provided
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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