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 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Additional 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, bending the aquabeam robotic system handpiece.The reported event 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 because of the reported event.

Manufacturer Narrative

H3.Device evaluation by manufacturer: the aquabeam handpiece and associated aquabeam scope were returned for investigation.Visual inspection confirmed that the scope and handpiece were stuck together; the handpiece was bent at the probe.The probe was bent at approximately 6.26in from the manifold.Cracks were observed on the manifold adhesive of the handpiece.A review of the aquabeam robotic system's log file was reviewed, which confirmed a delay of approximately 10 minutes and 23 seconds when the handpiece and scope were replaced.A review of the device history records (dhr) was conducted for aquabeam robotic system/serial number (b)(6) and aquabeam handpiece/lot number 20c00117, 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/handpiece met all design and manufacturing specifications when released for distribution.A review for similar complaints confirmed no other similar events reported to procept biorobotics.A revew of the aquabeam robotic system user manual, um0101 rev f, states: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup states: -hold the distal end of the scope tube tip approximately 1 inch (2.54cm) 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 revew of the aquabeam robotic system instructions for use, ifu0101-00 rev e, states: 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 was determined to be user-related.There were cracks in the manifold adhesive from a compressive load due to tenting the prostate during the procedure.Mishandling of the scope during setup and positioning can increase the chances of failures.The aquabeam robotic system's user manual and instructions for use contains adequate to address 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: 10805687
• MDR Text Key: 215555612
• Report Number: 3012977056-2020-00062
• 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: 05/25/2021

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: 11/06/2020
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1