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 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Product return is not available as the system in currently in use at the user facility.Investigation by manfacturer is currently in-process.

Event Description

A male patient with history of hypertension underwent an aquablation procedure for symptomatic benign prostate hyperplasia (bph).Post procedure, the patient was taken back to the operating room to treat bleeding (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure) due to remnant tissue presence at the median lobe of the prostate, which had been previously resected as part of the aquablation procedure.Cauterization was performed to remove the remnant tissue and control the bleeding without any further clinical sequela to the patient.The patient was reported to be in good condition.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

H.10 additional narrative/data: 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 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 complaints was performed on serial number (b)(6), which confirmed that there was one similar event reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.A root cause for the reported event could not be determined.Bleeding is a potential risk of the aquablation procedure.Based on 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.

Manufacturer Narrative

H.1 type of reportable event: the follow-up #1 was incorrectly reported as an malfunction.The correct selection should have been serious injury.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: 10228109
• MDR Text Key: 199313611
• Report Number: 3012977056-2020-00018
• 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,Followup
• Report Date: 04/23/2021

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: 06/03/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 10/02/2020; 04/15/2021
• Supplement Dates FDA Received: 10/12/2020; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention