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 Hemorrhage/Bleeding (1888)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the product is unavailable for investigation as it is currently in use at the user facility.Investigation by manufacturer is currently in-process.

Event Description

A male patient with medical history of being on eliquis anticoagulant medication underwent an aquablation procedure on (b)(6) 2020 for symptomatic benign prostatic hyperplasia (bph).The eliquis medication was stopped three (3) days prior to the aquablation procedure.On (b)(6) 2020, procept biorobotics corporation became aware that post aquablation the patient began bleeding and hematocrit levels decreased from 30% to 21% (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).The patient was administered two (2) units of blood transfusion and taken back to the operating room (or) for additional cauterization treatment to address the bleeding.The patient was administered two (2) additional units of blood transfusion.Information provided to procept biorobotics corporation determined that the patient had been given an injection of lovenox anticoagulant medication within 24 hours after the aquablation procedure (per manufacturer's instruction for use, patients must be able to safely stop anticoagulants or antiplatelet agents perioperatively).The patient is doing fine and has been discharged home.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

H3.Device evaluation by manufacturer: the aquabeam robotic system was not returned for investigation as it is currently in use at the user facility.A review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for ab2000-b rev d/serial number (b)(6) 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.A review for similar complaints under ab2000-b rev d/serial number (b)(6) confirmed no other similar events.A review of similar complaints across all lots confirmed a total of four (4) similar events.The aquabeam robotic system instructions for use, ifu0101-00 rev.E, states: 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: inability to safely stop anticoagulants or antiplatelet agents perioperatively.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists bleeding as a potential risk of the aquablation procedure.Based on the information provided by the treating physician that the patient was put back on anticoagulant medication lovenox 24 hours post-aquablation procedure, plus the review of the log file, 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: 11041950
• MDR Text Key: 227929852
• Report Number: 3012977056-2020-00084
• 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: 05/13/2021

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
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention