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

Model Number AB2000

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the hdmi to dvi-d and ethernet cables were discarded at the user facility; therefore, no physical investigation was able to be conducted.The information obtained by procept representative confirmed that both cables were replaced and the system functioned as intended.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.5.2 precautions: aquabeam robotic system setup.Ensure the aquabeam robotic system electrical connections are properly installed and secure.A review of the device history record (dhr) for aquabeam robotic system ab2000 /serial number (b)(4) was performed, which confirmed that there were no nonconformances, 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 root cause of the reported event could not be determined due to the inability to investigate both cables.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 (procep) became aware that during waterjet nozzle registration the aquabeam robotic system would not allow angle planning.As a result, the aquablation procedure was aborted.It was later determined by a procept representative that the issue was associated with faulty hdmi to dvi-d and ethernet cables, which were replaced with subsequent aquablation procedures completed without any further issues.There were no adverse health consequences to the patient due to the reported 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: 16072578
• MDR Text Key: 308285128
• Report Number: 3012977056-2022-00175
• Device Sequence Number: 1
• Product Code: PZP
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/30/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male