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

Catalog Number AB2000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the aquablation procedure, the aquabeam scope was unable to provide clear visualization after insertion into the patient.The treating surgeon observed that the cysto view was darker than usual, even with the light intensity turned to the maximum.As a result, the treating surgeon decided to abort the aquablation procedure and converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to this event.

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.

Manufacturer Narrative

The aquabeam scope was returned for investigation.Visual inspection observed to have no physical damages or anomalies.Functional testing confirmed the reported event.The scope produced a blurry image.The scope distal tip was viewed under magnification.Adhesive degradation was seen on the inner and outer lumen.The root cause of the reported event is undeterminable as the cause of the poor visualization is unknown.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam scope / lot number $$72118/s0050 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 was reviewed.The current user manual um0101-00 rev.F, aquabeam robotic system user manual was reviewed.11.2.5 sterile: aquabeam handpiece and aquabeam scope setup · verify the aquabeam scope visualization by viewing the image through the camera source port (the eyepiece).If any defect in the image is observed, check the cleanliness of the optical surfaces (distal and proximal lenses).The lens should appear smooth and shiny.Poor cleanliness of exterior surfaces can cause a foggy or cloudy image.Note: obtain a new aquabeam scope if proper visualization cannot be verified.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; 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: 18164759
• MDR Text Key: 328512027
• Report Number: 3012977056-2023-00224
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20211027L
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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 Sex: Male