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 Perforation (2001)

Event Date 01/24/2024

Event Type  Injury  

Event Description

A male patient with a 58g prostate underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Initial placement of the tools was difficult due to a 300cc - 400cc hydrocele in the patient's left testicle.The hydrocele was drained prior to starting the aquablation planning.During aquablation planning, difficulty was experienced with identifying where the bladder neck was located.As a result, the treating surgeon planned to stay conservatively over the top of the bladder neck.Procept biorobotics corporation became aware that during the first treatment pass, the aquabeam handpiece high-velocity waterjet appeared to undermine the bladder neck.The treating surgeon proceeded with a second treatment pass.During hemostasis, the left ureteral orifice (uo) was unable to be located.The treating surgeon believes that the waterjet cleaved the left uo into two.The patient was treated with traction and a foley catheter and was discharged two (2) days after aquablation therapy.The patient's catheter was removed on (b)(6) 2024 and he passed a voiding trial.No malfunction of the aquabeam robotic system was reported.

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.

Manufacturer Narrative

H10.Additional manufacturer narrative: on 27-feb-2024, additional information was received.It was reported that the patient had a computed tomography (ct) scan which showed that the patient has a congenital absence of the left kidney and subsequently no left ureteral orifice that could have been resected as originally feared.It was reported that the treating surgeon is happy with how the patient is doing.

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 log files, device history record (dhr), and instructions for use (ifu).A review of the device history record (dhr) ab2000-b/serial number: (b)(6) was conducted, which confirmed that there were no non-conformance's, 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: 4.3.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bladder or prostate capsule perforation.A root cause of the reported event could not be determined.The aquabeam robotic system instructions for use lists prostate capsule perforation as a potential risk of the aquablation procedure.Based on the information received, plus a review of the treatment log files, ifu and dhr, the event is considered not device-related.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
• MDR Report Key: 18727718
• MDR Text Key: 335723482
• Report Number: 3012977056-2024-00035
• Device Sequence Number: 1
• Product Code: PZP
• 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,Followup
• Report Date: 04/01/2024

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?: Yes
• 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: 01/24/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 03/27/2024
• Supplement Dates FDA Received: 03/13/2024; 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male