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 Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 07/29/2020

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 underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that the patient had undergone insertion of a suprapubic catheter (not a procept-biorobotics' device) two (2) days prior to the aquablation procedure.Post-aquablation procedure, during hemostasis, the patient's abdomen became distended; therefore, the physician converted to an open surgery, which confirmed a bladder perforation next to the suprapubic catheter ostium.The physician confirmed that the bladder perforation was not related to the aquablation procedure.Ultimately, the patient was left open with packing due to bleeding and scheduled to return for removal of the packing and closure at a later date.The physician confirmed that the event did not occur as a result of a malfunction of the aquabeam robotic system.

Manufacturer Narrative

H.10 additional narrative/data: 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 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 were no other similar events.No similar events have been reported across all other systems.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.D, 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.A root cause for the reported event could not be determined as the product was not returned for investigation.The treating physician confirmed that the reported event is unrelated to the aquablation procedure.Based on the information received and 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

For corrected data refer to h.6 event problem and evaluation codes, patient code(s).

• 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: 10399774
• MDR Text Key: 202689701
• Report Number: 3012977056-2020-00037
• 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: 08/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention