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

Model Number 210101

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure.No system malfunctions were observed.A review of the device history record (dhr) for the aquabeam system, lot number 18c00639, 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 events was conducted on the aquabeam robotic system, lot number 18c00639, which confirmed that there were no other similar events reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu0101, rev.C, 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.In addition, do not use the system in the following: unable to safely stop anticoagulants or antiplatelet agents perioperatively.4.3.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding.The system was not returned for investigation of this event.Bleeding is a potential risk of the aquablation procedure.Per the ifu, the patient must be able to safely stop anticoagulant agents perioperatively.Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.

Event Description

A male patient underwent an aquablation procedure.The patient had a medical history of being on levonox and pradaxa anticoagulant medications (per the manufacturer's instructions for use, patients must be able to safely stop anticoagulant agents before surgery).Twenty-four hours post discharge, the patient was readmitted due to bleeding (per manufacturer's instructions for use, bleeding is a potential risk of the aquablation procedure).The patient received a blood transfusion (number of units unknown) and was reported to be in good condition with no further clinical sequela.No malfunction of the aquabeam system was reported.Additional information was received that the patient was put back on levonox and pradaxa approximately after 12 hours post-surgery.

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, ca ; 2327291
• MDR Report Key: 9860862
• MDR Text Key: 188341518
• Report Number: 3012977056-2020-00011
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B6142101011
• UDI-Public: B6142101011
• 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
• Report Date: 03/20/2020

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: 210101
• Device Catalogue Number: 210101
• Device Lot Number: 18C00639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention