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 06/23/2020

Event Type  Injury  

Manufacturer Narrative

Product return is not available as the system in currently in use at the user facility.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A male patient with clinical history of being on anticoagulant medication underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that 10 days post-aquablation procedure, after being placed back on anticoagulant medication, the patient was taken back to the operating room due to bleeding (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).Catheterization was performed to address the bleeding.The patient was reported to be in good condition.There were no adverse health consequences with the patient because of this event.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

Additional manufacturer narrative: for corrected data refer to section b5.Describe even or problem.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A male patient with clinical history of being on anticoagulant medication underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that 10 days post-aquablation procedure, after being placed back on anticoagulant medication, the patient was taken back to the operating room for clot evacuation, no bleeding was observed.No catherization was performed with this patient.The patient was reported to be in good condition.There were no adverse health consequences with the patient because of this event.No malfunction of the aquabeam robotic system was reported.

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 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 no other similar events reported on this system.No other similar events have been reported across all other systems.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.A, was reviewed and states the following: warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.A root cause for the reported event could not be determined as the product was not returned for investigation.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.

• 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: 10371424
• MDR Text Key: 202690077
• Report Number: 3012977056-2020-00032
• 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: 11/30/2020

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: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 07/06/2020; 11/25/2020
• Supplement Dates FDA Received: 08/05/2020; 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention