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

Catalog Number AB2000

Device Problem Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that during the aquablation procedure, excess fluid was observed to be draining around the aquabeam handpiece when fully inserted into the bladder.Multiple troubleshooting attempts were made without success.A second aquabeam handpiece was used but the issue persisted.The treating surgeon planned the case conservatively and proceeded with case.It was also reported the bladder neck was undermined.As a result, the foley balloon catheter was left in place for an extended period.The patient was reported to be doing well and discharged from the hospital.

Manufacturer Narrative

H6: health effect: clinical code.4581 - undermined bladder neck - a rare complication of transurethral resection or incision of the prostate.It can occur when the bladder neck and proximal prostatic urethra are excessively resected.Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

Three (3) good faith attempts were made to retrieve the device; however, the aquabeam handpiece was not returned for investigation.The aquabeam robotic system's treatment logs file was reviewed, which indicated that the treatment was completed without any issues.It was not possible to determine what caused the undermining of the bladder and cannot be confirmed to be attributed to the handpiece issue.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c00627 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 current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.4.3 warnings: procedure.Throughout the procedure, monitor the patient for unanticipated movement and immediately release the foot pedal to stop the procedure if movement is observed.Patient movement during the procedure may result in serious injury.· ensure the motorpack magnetic latch is pointing towards the black indicator.Clear any excess drape and seams off the magnet plate on the motorpack.Patient/user injury could occur with unanticipated movement of the motorpack.· active fluid evacuation/aspiration from bladder is operational during the aquablation procedure but be attentive for any occluding tissue in the aspiration tubing during the procedure.·the aspiration tubing should not be bent, kinked, or twisted at any point during the aquablation procedure.Bending, kinking, or twisting the aspiration tubing may result in inefficient fluid aspiration.The aquabeam robotic system ifu, ifu0101-00 rev e, states the following: 8.11 sterile: attach the input end of the aspiration tubing (the end without an arrow on it) to the port located on the side of the aquabeam handpiece.Pass the other end of the aspiration tubing (the end that does have an arrow) to a non-sterile technician.Caution: ensure that the input end of the aspiration tubing stays in the sterile environment to avoid minor infection(s).8.12 non-sterile: locate the peristaltic pump on the user's left side of the console (when facing the front of the console).The aspiration tube guide is adjacent to the peristaltic pump.Press the key found near the middle of the aspiration tubing into the gray slot in the tube guide, in order to activate the switch.Ensure that the key is fully inserted into the slot.Open the peristaltic pump head and place the aspiration tubing inside the pump head.Carefully close the cover while ensuring the aspiration tubing is centered within the front and back jaws.Caution: verify that the tubing joints are securely attached to the peristaltic pump and that the tubing is correctly installed.Ensure the aspiration tubing is not pinched at the jaws located in the front and back side of the peristaltic pump.Failure to verify the proper installation may result in inefficient fluid aspiration due to poorly connected or damaged tubing.8.13 non-sterile: attach the outlet end of the aspiration tubing (the end with the arrow) to the fluid outlet receptacle.Warning: the aspiration tubing should not be bent, kinked, or twisted at any point during the aquablation procedure.Bending, kinking, or twisting the aspiration tubing may result in inefficient fluid aspiration.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bladder or prostate capsule perforation.The root cause of the reported event could not be established as the handpiece was not returned for investigation.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; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18178462
• MDR Text Key: 328643793
• Report Number: 3012977056-2023-00218
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221122C
• 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: 02/02/2024

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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 Outcome(s): Other
• Patient Sex: Male