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 01/19/2023

Event Type  Death  

Event Description

On (b)(6) 2023, a male patient underwent an uneventful aquablation procedure for symptomatic benign prostatic hyperplasia (bph).On (b)(6) 2023, procept biorobotics corporation (procept) became aware that post aquablation procedure the patient had expired on (b)(6) 2023.The patient presented with a clinical history of clots and pulmonary issues prior to the aquablation procedure but received clearance during a pre-operative pulmonary evaluation.The treating surgeon administered tranexamic acid (txa) to the patient during the aquablation procedure.The aquablation procedure was completed uneventfully and the aquabeam robotic system was used in accordance with its instructions for use.The treating surgeon indicated that the patient was discharged from the hospital with pulmonary clearance three days post-aquablation procedure.Twelve days post-discharge, the patient went to a different hospital with chest pain and expired from a pulmonary embolism.The treating surgeon stated that no autopsy was being planned on the patient and no internal investigation was conducted either.The treating surgeon confirmed that the aquabeam robotic system functioned as intended.

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

H.1: correction death.

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 22c01894 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: 3.Contraindications do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o embolism investigation of the treatment log files, device history record, labeling/i fu, and information received through the treating surgeon confirmed that no device malfunction occurred and the aquabeam robotic system functioned as intended and was used in accordance with its instructions for use.The reported event was determined 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: 16406006
• MDR Text Key: 309857901
• Report Number: 3012977056-2023-00020
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220627S
• 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,Followup
• Report Date: 08/25/2023

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: 01/20/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 04/24/2023; 08/25/2023
• Supplement Dates FDA Received: 05/17/2023; 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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): Death
• Patient Sex: Male