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 Urinary Retention (2119)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure.No system malfunctions were observed.A review of the device history record (dhr) for the aquabeam robotic system, lot number 19c00447, was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event.The review indicated that the system met all required specifications when released for distribution.A review for similar events was conducted on the aquabeam robotic system, lot number 19c00447, which confirmed there were no other similar events reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu310301, rev.F, was reviewed and urinary retention is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.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.

Event Description

A male patient underwent an aquablation procedure on (b)(6) 2019 and discharged home two (2) days later.Two (2) days post discharge, the patient presented to the emergency room with urinary retention (per manufacturer's instructions for use, urinary retention is listed as a potential perioperative risk of the aquablation procedure) and what appeared to be clots in the bladder.The patient was sent to the operating room for clot evacuation of the bladder.A cystoscopic procedure confirmed no clots were present in the bladder, but rather an intravesical prostatic protrusion, which was likely causing the urinary retention.Procept has conducted multiple attempts to gather additional information from the treating physician regarding course of action taken and condition of the patient without success.No further information has been provided to procept.No malfunction of the aquabeam robotic system was reported.

• 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, ca ; 2327291
• MDR Report Key: 9775045
• MDR Text Key: 188341255
• Report Number: 3012977056-2020-00007
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2020

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
• Device Lot Number: 19C00447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention