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

Model Number AB2000

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Per a user facility voluntary report submitted through the fda's medwatch program, procept biorobotics corporation (procept) became aware that a male patient underwent an aquablation procedure for benign prostatic hyperplasia (bph) in (b)(6) 2023.The provider submitted this event on behalf of the patient.The provider reports an increase in the patient's prostatic-specific antigen (psa) levels after undergoing aquablation treatment.The provider indicated that there has been a significant psa level increase, which could be associated with using the aquabeam robotic system.The provider indicated still doing research and the patient is currently under his/her care.No further details were provided to nor was procept made aware of this event by the user facility.

Manufacturer Narrative

Investigation is currently in process by manufacturer, no root cause has yet been established.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the 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 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'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.No further details were provided nor was procept biorobotics made aware of this event by the user facility.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; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494 ; 6502327291
• MDR Report Key: 16600303
• MDR Text Key: 311928658
• Report Number: 3012977056-2023-00038
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• 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
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Male