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

Model Number AB2000

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer for investigation.The investigation is currently in-process.

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 treating physician encountered difficulty advancing the aquabeam robotic system handpiece and aquabeam robotic system scope into the patient, which caused a procedural delay of over 20 minutes.The aquabeam robotic system handpiece and aquabeam robotic system scope were replaced and the procedure was successfully completed.There were no adverse health consequences to the patient as a result of the reported event.

Manufacturer Narrative

H.3 device evaluation by manufacturer: the aquabeam handpiece and associated aquabeam scope were returned for investigation.The reported event was able to be reproduced by manually attempting to translate the scope tip.The handpiece was bent.No evidence of galling was found with the handpiece.Attempts to remove the scope carriage by rotating the knobs on either of the scope carriage were made without success.The adhesive at the aspiration and irrigation tube bonds were inspected under a microscope.Cracks in the adhesive were observed indicating excessive force experienced by the joint.A review of the device history record (dhr) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system and/or handpiece associated to this event.The review indicated that the system and/or handpiece met all required specifications upon release for distribution.A review for similar complaints confirmed a total of four (4) similiar events reported on this issue.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.B, states the following: 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 aquabeam robotic system's user manual, um0104-00 rev.F, states the following: 11.2.5 sterile: aquabeamhandpiece and aquabeam scope setup states: -retract the scope tube tip on the aquabeam handpiece to 1 inch (2.54 cm) in front of its fully proximal position.-verify the aquabeam scope visualization via the camera source port.Note: obtain a new aquabeam scope if proper visualization cannot be verified -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.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.-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 theaquabeam scope.The root cause of the scope tip translation issue was determined to be due to a bent telescoping tube from a compressive load due to tenting the prostate during the procedure as evidenced by cracks on the manifold adhesive.The aquabeam robotic system's instructions for use and user manual contain adequate information regarding this issue.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: 10709007
• MDR Text Key: 212339383
• Report Number: 3012977056-2020-00051
• 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: 05/14/2021

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: 10/29/2020
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1