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 Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 07/29/2022

Event Type  Injury  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that during treatment a prostatic capsule perforation occurred in the patient requiring a blood transfusion.Procept confirmed that the capsule perforation occurred due to the resection angle extending beyond the purple depth reference marker.Per the manufacturer's instructions for use, prostate capsule perforation and bleeding are perioperative risks of the aquablation procedure.Additionally, the ifu provides instructions to ensure the resection angle is not set beyond the prostate capsule and ensure the contour does not extend beyond the desired resection region.Failure to do so may result in prostatic capsule perforation.The patient was reported to be in good condition.

Manufacturer Narrative

Additional manufacturer narrative: 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

H.10 additional 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.G / serial number (b)(6) 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.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: bleeding; bladder or prostate capsule perforation.5.6 precautions: procedure: when in the transverse trus view, ensure the resection angle is not set beyond the prostate capsule.When in the sagittal trus view, ensure the contour does not extend beyond the desired resection region.Failure to do so may result in prostatic capsule perforation.Ensure that the linear array of the trus probe is coplanar along the length of the aquabeam handpiece.Failure to do so may result in unintentional resection of prostatic tissue resulting in patient injury.Procept confirmed that the capsule perforation occurred due to the resection angle extending beyond the purple depth reference marker.Per the manufacturer's instructions for use, prostate capsule perforation and bleeding are perioperative risks of the aquablation procedure.Additionally, the ifu provides instructions to ensure the resection angle is not set beyond the prostate capsule and ensure the contour does not extend beyond the desired resection region.Failure to do so may result in prostatic capsule perforation.Based on the information received, plus the review of the event 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: 15307402
• MDR Text Key: 298766113
• Report Number: 3012977056-2022-00110
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20211001C
• 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: 11/14/2022

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: 07/29/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male