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 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

Root cause of the reported event has not yet been established.Investigation my 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 and aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the aquablation procedure, one of the functions on the aquabeam motorpack did not work during the second treatment pass.Troubleshooting steps taken to resolve the issue were unsuccessful.As a result, the second treatment pass was unable to be completed.There were no adverse health consequences to the patient due to the event.

Manufacturer Narrative

The aquabeam motorpack was returned for investigation.Visual inspection of the returned device was observed to have no physical damages or anomalies.Functional testing of the device confirmed the reported event.The aquabeam motorpack was disassembled and reassembled with a functioning electrical component, and the device worked as intended.The root cause of the reported failure mode is attributed to the failure of the electronic component.A review of the device history record (dhr) (b)(4) / serial number (b)(6) and aquabeam motorpack / lot number 22c04354 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 current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece drape the motorpack with camera drape.Recommended that a nonsterile technican pass the motorpack to a sterile technician by feeding the motorpack into the opening of the drape.Form a tight seal around the recessed area where the aquabeam handpiece will be attached: pre-stretch the elastic region to reduce risk of tears when seating it in recess of the motorpack.Ensure the drape is properly seated in recess of the motorpack.Ensure the drape is not obstructing the magnetic plate on the motorpack.Caution: pull the drape back to recess of the motorpack.Warning: to avoid potential contamination of the motorpack, ensure it is draped with a new sterile drape for each procedure.Ensure the high-pressure tubing is centered and seated in the lower box.Dock the motorpack to the aquabeam handpiece: verify aquabeam handpiece nozzle position (i.E.The movement of the blue led) homes to the base of the aquabeam handpiece (fully proximal).Apply sterile tape over the connection between aquabeam handpiece and motorpack to seal it.Tape over the beige high-pressure tubing and under the black aquabeam scope.Keep the motorpack and the aquabeam handpiece assembly with the scope clamp assembly in a secure and sterile environment.Note: verify the motorpack is securely engaged to the aquabeam handpiece by attempting to pull the aquabeam handpiece off of the motorpack.The aquabeam handpiece should remain connected to the motorpack if properly engaged.Submission of this report does not constitue 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065 ; 6502327291
• MDR Report Key: 17683458
• MDR Text Key: 322640497
• Report Number: 3012977056-2023-00145
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221216G
• Combination Product (y/n): Y
• 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: 11/17/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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