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

Model Number AB2000

Device Problem Break (1069)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4).The device has not yet been returned to the manufacturer for investigation.The investigation 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 procedure the aquabeam robotic system trus articulating arm was accidentally broke, therefore, the aquablation procedure was aborted.The aquablation procedure was to be rescheduled for a later date.No adverse health consequences were reported with the patient due to this event.

Manufacturer Narrative

H3.Device evaluation by manufacturer: the aquabeam robotic system trus articulating arm was returned for investigation.Visual inspection confirmed the arm joint to be detached with the bearings exposed, consistent with the reported event.A review of the device history records (dhr) for ab2000-b rev c/serial number (b)(6) and fg220801 rev e/lot number 19c00474 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 devices met all design and manufacturing specifications when released for distribution.A review for similar complaints confirmed no other similar events have been reported to procept.The aquabeam robotic system's user manual (ifu), ifu0101-00, rev.F, was reviewed and states the following: 4.2 warnings: procedure setup: -ensure the handpiece articulating arm and the trus articulating arm are securely mounted to the surgical table bedrail to prevent unanticipated movement during the aquablation procedure.Figure 9: aquabeam handpiece articulating arm: 7.7 aquabeam trus articulating arm: -the aquabeam trus articulating arm (figure 10), a re-usable component of the aquabeam robotic system, connects to standard bedrails and fixes the trus probe and stepper in position relative to the patient.The trus articulating arm has a release trigger that enables freedom of movement and locking of the arm.The trus articulating arm performs the following functions: · connects to the trus probe and stepper · provides stability of the trus probe throughout the procedure the reported event was confirmed during in-house investigation.The root cause of the reported event was determined to be user related, as the operator inadvertently lowered the bedrail causing the arm joint to break.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; 900 island drive; suite 101; redwood city CA 94065 1494
• MDR Report Key: 10997956
• MDR Text Key: 221249727
• Report Number: 3012977056-2020-00078
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 06/12/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1