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

Model Number AB2000

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure the aquabeam scope bent, causing the aquabeam handpiece scope carriage to be unable to advance forward.The scope was replaced with a new unit and the procedure was successfully completed.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the procedural delay.

Manufacturer Narrative

Investigation is currently in process by manufacturer, no root cause has yet been established.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam scope was returned for investigation of this event.Visual inspection confirmed the reported event as bending was on the semi-flexible hypotube.A review of the device history record (dhr) ab2000-b/serial number (b)(6) and associated aquabeam scope/ serial number (b)(6) 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 aquabeam robotic system user manual, um0101 rev.F, states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup · 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.Note: do not use excessive force to advance the aquabeam scope.If resistance is felt,gently rotate the aquabeam scope clockwise and counterclockwise while simultaneously applying forward pressure.A similar complaint review for a 12-month period was conducted, which confirmed two (2) similar events have been reported to procept.The user manual explicitly mentions how to reduce scope breakages - "note: do not use excessive force to advance the aquabeam scope.If resistance is felt, gently rotate the aquabeam scope clockwise and counterclockwise while simultaneously applying forward pressure." although the in-house investigation confirmed the reported failure mode, the root cause was unable to be established.Complaint data is monitored and trended as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.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
• 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: 14940581
• MDR Text Key: 303242775
• Report Number: 3012977056-2022-00086
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20211001C
• 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: 07/25/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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