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 Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 02/14/2024

Event Type  Injury  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Prior to the aquablation procedure, the patient presented to the operating room with bleeding at the bladder neck or in the prostate.Cautery had been attempted a few days before to control hematuria; however, the hematura persisted, and the patient came to the operating room with one unit of blood.The treating surgeon thought that the patient would benefit from aquablation and that cautery at the end of the aquablation procedure would resolve the patient's bleeding.It was reported that the patient had a large prostate.Procept biorobotics corporation (procept) became aware that post aquablation procedure, catheter placement was difficult, even under ultrasound imaging, therefore the surgeon used a guide catheter to assist with catheter placement.While irrigating the catheter, clots and bleeding were noted and the treating surgeon went back to perform more fulgeration.When the treating surgeon was finished, he catheterized the patient again with the assistance of a guide catheter and ultrasound imaging.While attempting to bring the patient off the operating table, it was noted that the patient's stomach was swollen.The treating surgeon immediately pivoted to an open procedure to relieve the fluid build up that was noted around and behind the patient's bladder.The issue was resolved with a urethral catheter and suprapubic catheter.The treating surgeon believes that the perforation was caused by the guide catheter.The patient is reported to be doing fine and he had a catheter for approximately one week.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

Additional information received on 01-apr-2024 from the sales representative indicating that he reviewed the treatment log files and that there was no confirmation of bladder perforation.The sales representative discussed with the treating surgeon who concluded that he must have perforated at the first attempt to place the catheter.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-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.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.The aquabeam robotic system was not returned for investigation of this complaint.The treating surgeon believes that the perforation occurred during first attempt at placing a catheter with a catheter guide.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of the aquablation procedure.Based on the event details plus a review of the treatment log files, dhr, and ifu the event is considered not to be 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: 18895625
• MDR Text Key: 337565585
• Report Number: 3012977056-2024-00057
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221121O
• 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: 04/15/2024

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?: 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: 02/14/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2022
• 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