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

Model Number AB2000

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 05/12/2022

Event Type  Injury  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).A cystoscopy procedure performed prior to the aquablation treatment revealed patient anatomy with a very narrow urethra, high bladder neck, and trabeculated bladder.During the aquablation procedure, an erection occurred during the aquabeam handpiece insertion making positioning difficult.The aquabeam scope tip was in front of the sphincter and had a good cystoscopic view.The treating surgeon planned conservatively, especially around the middle lob and bladder neck, and completed the aquablation procedure.After clot evacuation was performed it was observed that the verumontanum and sphincter were partially damaged outside the resected area.Additionally, during bladder inspection, a bladder tumor was discovered, and cancer was suspected; therefore, transurethral resection of the bladder (tur-b) procedure was performed.Additional information received through the treating surgeon indicated that the patient was discharged home and is recovering well.The treating physician indicated that it is possible that the mucous membrane was just torn.Additional information has been requested on this, including action taken to address the reported injury.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.

Manufacturer Narrative

The aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.The investigation consisted of a review of the information reported to procept, plus a review of the event log files, device history record (dhr), and labeling.The aquabeam robotic system's treatment log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment log file indicated that the system functioned as designed.A review of the device history record (dhr) ab2000-b rev.C/serial number 19c01039 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 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 perforation 8.24 sterile: align waterjet nozzle by doing the following: a.Rotate the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with the vertical yellow line.B.Press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on trus stepper).C.Waterjet needs to be visible at 3 or 9 o'clock.D.If slightly off, depress the black button on the mag block (located on the handpiece articulating arm) and rotate the aquabeam handpiece axis while stepping on foot pedal to align jets to 3 and 9 o'clock position.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of the aquablation procedure.Based on the event details plus a review of the log files, dhr, and ifu the event is considered not to be device-related.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: 14569522
• MDR Text Key: 293351120
• Report Number: 3012977056-2022-00073
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190808W
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/12/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2019
• 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