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

Model Number	210101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• MDR Report Key: 9860862
• Report Number: 3012977056-2020-00011
• Device Sequence Number: 3700169
• Product Code: PZP
• UDI-Device Identifier: B6142101011
• UDI-Public: B6142101011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 210101
• Device Catalogue Number: 210101
• Device Lot Number: 18C00639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention