MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Model Number AB2000

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: 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

Procept biorobotics corporation became aware that at the start of aquablation procedure, and prior to waterjet ablation, the patient bladder neck was too high for the aquabeam handpiece to enter the bladder; therefore, the handpiece was removed, and the urologist inserted a resectoscope to remove some of the tissue at the bladder neck.During this step, the resectoscope resected through the bladder neck and subsequently through the rectal wall (per manufacturer's instructions for use, bladder perforation and rectal perforation are potential perioperative risks of the aquablation procedure).A colorectal surgeon was called in to repair the rectal perforation and the urologist repaired the bladder neck perforation.The patient was given a suprapubic catheter, stayed in the hospital for a few days, and was discharged home.No malfunction of the aquabeam robotic system occurred during this event as the issue occurred prior to the aquablation procedure.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr), and labeling.A review of the device history record (dhr) ab2000-b / serial number (b)(6) was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, 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 bladder or prostate capsule perforation.A root cause for the reported event could not be determined.The issue occurred prior to aquablation procedure with the loop (non-procept device).The aquabeam robotic system's ifu lists rectal perforation and bladder perforation as a potential risk of the aquablation procedure.Based on the event details plus a review of the dhr and ifu the event is considered not to be device-related.Submission of this report does not constitue an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr), and labeling.A review of the device history record (dhr) ab2000-b / serial number (b)(6) was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, 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 bladder or prostate capsule perforation, o rectal incontinence/perforation.A root cause for the reported event could not be determined.The issue occurred prior to aquablation procedure with the loop (non-procept device).The aquabeam robotic system's ifu lists rectal perforation and bladder perforation as a potential risk of the aquablation procedure.Based on the event details plus a review of the 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 16533522
• MDR Text Key: 311201546
• Report Number: 3012977056-2023-00032
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$721C00848/16D20210511G
• 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,Followup,Followup
• Report Date: 12/19/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 04/24/2023; 12/15/2023
• Supplement Dates FDA Received: 05/11/2023; 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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
• Patient Sex: Male