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

Model Number AB2000

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

Patient Problems Hemorrhage/Bleeding (1888); Bowel Perforation (2668)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Investigation by manufacturer is currently in-process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure a rectal perforation occurred.The transrectal ultrasound (trus) probe most likely caused the perforation (per manufacturer's instructions for use, rectal perforation is a potential perioperative risk of the aquablation procedure).The transrectal ultrasound (trus) probe is a non-procept biorobotics' device.In addition, a left pedundal artery wound was reported.The patient underwent a laparoscopy, colostomy, and transrectal drainage to collect waste material.Additionally, the patient received two (2) units of blood transfusion due to a decrease in hemoglobin levels post-aquablation procedure (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).Additional information regarding current patient condition has been requested.

Manufacturer Narrative

H.10 additional narrative/data: additional information confirmed that the patient is doing well in regards of the severity post aquablation procedure.The patient had surgery to close the colostomy from the rectal side.The physician made a cystoscopy and found a stone in the urethra, which was removed.Urethra is at risk of stenosis.Patient is doing self-catheterization due to incontinence.Erectile disfunction is likely permanent.The rectal perforation was probably due to the patient waking up during anesthesia.A review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for serial number 19c00568 was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed that there were no other similar events reported on this system.There are four (4) other similar events of rectal perforation that have been reported across all other systems.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.A, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding, incontinence or overactive bladder, rectal perforation, sexual dysfunction, including ejaculatory and erectile dysfunction.A root cause for the reported event could not be determined.The aquabeam robotic system ifu's lists bleeding, incontinence, rectal perforation, and sexual dysfunction, including erectile dysfunction, as potential risks of the aquablation procedure.Based on the review of the log file, dhr and ifu, the event is considered not to be procept device related.The transrectal ultrasound (trus) probe is a non-procept biorobotics device.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 1494
• MDR Report Key: 10709003
• MDR Text Key: 212261251
• Report Number: 3012977056-2020-00055
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention