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 Laceration(s) (1946)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.This report is being reported over the 30 calendar days reporting timeline as reassessment of the event determined that the event meets the criteria of a reportable event under 21 cfr part 803.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during procedure alignment, the treating surgeon inadvertently pressed the prime button instead of the foot pedal, hitting the patient's bladder wall.Upon checking via a resectoscope it was confirmed that the bladder wall was hit but no disruption through was seen; however, the treating surgeon proceeded to cauterize the area to prevent any possible damage.No malfunction of the aquabeam robotic system was reported.Procept confirmed that the patient is doing fine and there are no lasting side effects, and no further treatment was required as a result of this event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this complaint.The in-house investigation consisted of a review of the event log files, device history record (dhr), labeling and information provided by the customer.A review of the device history record (dhr) for the ab2000-b rev.C/serial number (b)(6) was performed, 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 and motorpack met all design and manufacturing specifications when released for distribution.The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.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.The information received indicated that the treating surgeon inadvertently pressed the prime button instead of the foot pedal, hitting the patient's bladder wall.The aquabeam robotic system's ifu contains adequate instructions on pressing the foot pedal to visualize the position of the waterjet.Based on the information received, plus the review of the log file, 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: 14349956
• MDR Text Key: 293691818
• Report Number: 3012977056-2022-00043
• 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: 08/22/2022

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: 01/27/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/22/2022
• 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): Required Intervention
• Patient Sex: Male