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

Catalog Number 220101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/25/2021

Event Type  Injury  

Event Description

On 18-april-2022, procept biorobotics corporation became aware of an article published on 25-jan-2021 in the investigate and clinical urology (icurology) that included details of 14 adverse events reported in patients within 90 days of undergoing an aquablation procedure.Most procedural-related adverse events were classified as clavien-dindo grade 1 or grade 2.This event is being submitted for one (1) of five (5) events classified as clavien-dindo 2 due to deep vein thrombosis (dvt) managed with anticoagulant medication.One (1) of the five (5) events was classified as clavien-dindo 2 due to a capsular perforation requiring prolonged catheterization of approximately 20 days was previously submitted by procept under mfr.Report #3012977056-2020-00004; no new report is required on this event.No grade 4b or grade 5 complications were noted.No device malfunction was reported during these procedures.The manufacturer's user manual list bleeding as a potential risk of the aquablation procedure.All pertaining information available to procept biorobotic is being submitted with this report.This is report 9 of 13.

Manufacturer Narrative

A review of the aquabeam robotic system's log file could not be conducted as the date when the aquablation procedure took place is unknown.A review of the device history record (dhr) for serial number (b)(4) was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met all design and manufacturing specifications when released for distribution.Aquabeam robotic system user manual, um220101, was reviewed and states the following: procedure: as with any surgical urologic procedure, potential risks of the aquablation procedure include: o bleeding.A historical review for similar complaints confirmed no other similar events for deep vein thrombosis have been reported to procept biorobotics.A root cause for the reported event could not be determined.The aquabeam robotic system user manual lists bleeding as a potential risk of the aquablation procedure.No device malfunction was reported or confirmed through the investigation performed by procept.

• 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: 14431980
• MDR Text Key: 294762093
• Report Number: 3012977056-2022-00055
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B6142201011
• UDI-Public: +B6142201011/16D201802092
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 220101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2018
• 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): Required Intervention
• Patient Sex: Male