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 Pulmonary Embolism (1498)

Event Date 02/09/2023

Event Type  Injury  

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.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) was made aware that the patient developed a pulmonary embolism (pe) post aquablation procedure.The pe was reported to have no association with the aquabeam robotic system.No further information was obtained on this event.No malfunction of the aquabeam robotic system was reported during the aquablation procedure.

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 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: o embolism.A root cause for the reported event could not be determined.The aquabeam robotic system instructions for use embolism as a potential risk of the aquablation procedure.No further information was able to be obtained on this event.Based on the event details plus a review of the 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
• 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 94665 ; 6502327291
• MDR Report Key: 16615080
• MDR Text Key: 312009790
• Report Number: 3012977056-2023-00040
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$719C00570/16D201906055
• 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: 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: 02/23/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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