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 Perforation (2001)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Investigation by manufacturer is currently in-process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-aquablation procedure, and during resectoscope insertion, a bladder neck perforation occurred with the patient (per manufacturer's instructions for use, bladder or prostate capsule perforation are potential perioperative risks of the aquablation procedure).The foley balloon catheter was left in the patient for a longer period to allow the bladder neck to heal.The patient was reported to be in good condition.There were no reported adverse health consequences as result of the bladder neck perforation.No malfunction of the aquabeam robotic system was reported; the physician confirmed that the bladder neck perforation was unrelated to the aquablation procedure.

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 was one (1) other similar event reported on this system.There are four (4) other similar events that have been reported across all other systems.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.D, 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 prostate capsular perforation.5.6 precautions: procedure.When in the transverse trus view, ensure the resection angle is not set beyond the prostate capsule.When in the sagittal trus view, ensure the contour does not extend beyond the desired resection region.Failure to do so may result in prostatic capsule perforation.A root cause for the reported event could not be determined.Prostate capsular perforation is a potential risk of the aquablation procedure.Based on the information received, plus 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: 10767657
• MDR Text Key: 214106751
• Report Number: 3012977056-2020-00058
• 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: 01/08/2021

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: 10/01/2020
• Initial Date FDA Received: 11/01/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other