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 Cardiac Arrest (1762)

Event Date 06/07/2021

Event Type  Death  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.

Event Description

On (b)(6) 2021, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that the aquablation procedure was stopped, and the patient was transferred to the intensive care unit.On (b)(6) 2021, procept became aware that the patient had passed away.The treating physician reported that the patient had cardiac issues (specific detail of issues were not provided) and that the patient had been administered a blood transfusion.Following the blood transfusion, the patient's hemoglobin levels went from approximately 14 g/dl to 12 g/dl overnight.No malfunction of the aquabeam robotic system was reported to procept.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for 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 system met all design and manufacturing specifications when released for distribution.A review for similar complaints confirmed six (6) events have been reported to procept biorobotics.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.The aquabeam robotic system's instructions for use, ifu0101-00, warns of potential perioperative risks associated with the aquablation procedure, including bleeding, however, this event event was unlikely related to the aquablation procedure, based upon the opinion of the treating physician.The patient was transfused, which was related to surgery due to the aquablation procedure; however, the rest of complications were unrelated.Patient's hemoglobin levels were in normal range post transfusion.Based on the review of the log file, dhr, and the information from the treating physician, it is concluded that 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: 12112696
• MDR Text Key: 259972720
• Report Number: 3012977056-2021-00043
• 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: 10/20/2021

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: 06/11/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death