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

Model Number AB2000

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/21/2023

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 (procept) became aware that at the beginning of the aquablation procedure, the surgeon encountered difficulty positioning the aquabeam handpiece due to the patient's anatomy who presented with prior stricture.As the surgeon attempted to retract the aquabeam scope via the aquabeam handpiece scope carriage, the scope bent mid-shaft within the handpiece.As a result, the aquablation procedure was aborted and the surgeon was going to discuss with the patient other modalities of the treatment.No adverse health consequences to the patient were reported due to this event.

Manufacturer Narrative

Three (3) good faith attempts were made to retrieve the device; however, the aquabeam scope was not returned for investigation.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam scope / lot number 71905/s0049 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, (b)(4) rev.F aquabeam robotic system user manual, us, english was reviewed.11.2.5 sterile: aquabeam handpiece and aquabeam scope setup · visually inspect all surfaces of the aquabeam scope for any damage or wear.· discontinue use of the aquabeam scope if any of the following signs of damage are found.The root cause of the reported event could not be established as the aquabeam scope was not returned for investigation.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: 16968926
• MDR Text Key: 315695931
• Report Number: 3012977056-2023-00086
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20200424C
• 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: 07/17/2023

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 Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2020
• 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