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 Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Additional 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 (procept) became aware that the patient coded in the operating room (or).In the middle of the second treatment pass during the aquablation therapy, the patient presented with acute low blood pressure.The procedure was stopped approximately one and a half minutes prematurely and the surgeon went in with a resectoscope to achieve hemostasis; however, about one minute into hemostasis the patient coded.A code team was called in to stabilize the patient.The patient was taken to the intensive care unit and was later taken back to the operating room to continue cauterization and ensure adequate hemostasis around the bladder neck to control the bleeding.The patient was reported to be in stable condition.The surgeon was unable to determine what caused the reported event.No malfunction of the aquabeam robotic system was reported due to this event.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the treatment log files, the device history record (dhr), and labeling.The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.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's instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 3.Contraindications.Do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.A root cause for the reported event could not be determined.The reported event is unrelated to any alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the aquabeam robotic system.The treating surgeon was unable to determine what caused the reported issue.Once, the patient was reported stable, the patient was taken back to the operating room to perform cauterization to control bleeding.Based on the event details plus a review of the event log file, 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; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 16558786
• MDR Text Key: 311478049
• Report Number: 3012977056-2023-00034
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D202005012
• 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: 06/01/2023

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 Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male