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 Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Product return is not available as the system in currently in use at the user facility.Investigation by manfacturer is currently in-process.

Event Description

A male patient with an undisclosed clinical history of pulmonary embolism underwent an aquablation procedure for symptomatic benign prostate hyperplasia (bph).Post-procedure, the patient was taken back to the operating room for catherization to successfully address bleeding (per manufacturer's instructions for use, bleeding is a potential risk of the aquablation procedure).Additional information was later received that the patient's oxygen level began to decrease during the course of this process, and it was confirmed that the patient likely had a pulmonary embolism prior to the aquablation procedure.The patient was not on anticoagulants prior to the aquablation procedure.The patient was stable and in good condition; no anticoagulants were administered until further assessment post-procedure care was to be performed.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

A review of the device history record (dhr) for serial number (b)(6) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed that there was one similar event reported on this system.A review for similar events across all systems confirmed two (2) other similar events the aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.C, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.A root cause for the reported event could not be determined.Bleeding is a potential risk of the aquablation procedure.Based on the 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 1494
• MDR Report Key: 10228108
• MDR Text Key: 199313658
• Report Number: 3012977056-2020-00019
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• 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
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention