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

Catalog Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 07/06/2023

Event Type  Injury  

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 became aware that post-aquablation procedure, the treating surgeon observed blood discharge from the right ureteral orifice (uo).However, upon examination within the bladder, the uo appeared undamaged and unaffected.The procedure was successfully completed, but the next day, the patient developed hydronephrosis, leading to the placement of a nephroureteral stent.During this process, the doctor identified a minor hole or leak in the ureter.Upon a follow-up conversation and investigation, procept determined that there was no evidence of tissue damage around the uo that would suggest it was caused by the waterjet or loop used during the aquablation procedure.It was also reported that the patient had only one kidney, indicating the possibility of pre-existing conditions that could have contributed to the event.The patient is reported to be recovering well.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the treatment logs, device history record (dhr) and labeling.A review of the device history record (dhr) ab2000-b/serial number (b)(6) 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 aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: contraindications do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The device was not returned for investigation because it performed as intended during the aquablation procedure and was confirmed through our investigation of the event.The information received indicated that the event is related to a pre-existing patient condition that has no relation to the aquablation procedure.Based on the information received, plus the review of the treatment logs, dhr, and labeling this event is unrelated to the aquabeam robotic 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; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; suite 101; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; suite 101; san jose, CA 95134 ; 6502327291
• MDR Report Key: 17386014
• MDR Text Key: 319654156
• Report Number: 3012977056-2023-00123
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221026M
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male