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

Catalog Number AB2000

Device Problem Connection Problem (2900)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.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 during the aquablation procedural setup, the keyboard and mouse on the aquabeam roll stand were not functioning.A second keyboard and mouse were used to complete the procedure.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient as a result of this event.

Manufacturer Narrative

The aquabeam keyboard was not returned for investigation as it was disposed of at the user facility.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam roll stand / lot number 22c00695 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 failure.Keyboard p0687 lot 21a03613 was issued to this rollstand.The review indicated that the device met all design and manufacturing specifications when released for distribution the current user manual um0101-00, aquabeam robotic system user manual, us was reviewed.5.2 precautions: aquabeam robotic system setup · ensure the aquabeam robotic system electrical connections are properly installed and secure 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; 150 baytech dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18686877
• MDR Text Key: 335143645
• Report Number: 3012977056-2024-00034
• 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,Followup
• Report Date: 03/25/2024

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2022
• 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 Sex: Male