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

Model Number AB2000

Device Problems Mechanical Problem (1384); Material Twisted/Bent (2981)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: the aquabeam handpiece was not returned for investigation as it was discarded at the user facility.A review of the device history record (dhr) for aquabeam robotic system / serial number: (b)(4) and the aquabeam handpiece / lot number: 22c00882 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 system and its associated component 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 and instruction for use ifu0101-00 rev.E, aquabeam robotic system ifu, us, english were reviewed.Um0101-00 rev.F 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup states: while supporting the aquabeam handpiece, gently grip the middle of the semi-rigid section of the aquabeam scope and partially insert through the clear rubber seal on the bottom of the aquabeam handpiece.Hold the distal end of the scope tube tip approximately 1 inch (2.54 cm) from the fully proximal position and continue advancing the aquabeam scope forward until it is properly engaged with the aquabeam handpiece and then rotate the proximal key alignment adapter so that the dimple on the proximal key alignment adapter is facing up.An audible click should be heard when the aquabeam scope is securely engaged with the aquabeam handpiece.Confirm the aquabeam scope is fully engaged by advancing and retracting the scope proximal key and observing the scope tube tip moving in concert with the aquabeam scope.Scope disassembly: 11.2.21 aquabeam robotic system disassembly.Retract the scope carriage to the proximal end to remove the aquabeam scope from the aquabeam handpiece.Simultaneously depress the tab at the bottom of the aquabeam handpiece and push the scope carriage off the track.Rotate the scope proximal key adapter until grooves are perpendicular to the aquabeam handpiece track.Holding the aquabeam handpiece scope tube tip, rotate the scope proximal key adaptor about 30 degrees clockwise and counterclockwise while pulling the aquabeam scope out of the aquabeam handpiece.Ifu0101-00 rev.E: 5.1.Precautions: general: if excessive resistance is encountered during aquabeam scope positioning, reposition the aquabeam handpiece to minimize tenting the prostate in order to reduce the chance of damaging the aquabeam scope.The root cause of the reported event could not be determined due to inability to physically investigate the aquabeam handpiece.Complaint data is monitored and trended as part of procept's quality management system.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.No issues were found with the console.How the errors occurred remains undeterminable as no problems were detected during testing.

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 handpiece scope carriage was able to slide off the handpiece but was still functional.Upon insertion into the patient, the handpiece bent when the patient bucked.The handpiece was replaced with a new handpiece unit and the procedure was continued through successful completion.The reported events caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the procedural delay.

• 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 15626828
• MDR Text Key: 307091789
• Report Number: 3012977056-2022-00136
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$721C02032/16D20211229A
• 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
• Report Date: 10/18/2022

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: 09/20/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male