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

Model Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the aquablation treatment, during the second treatment pass, the patient bucked while being under anesthesia.The surgeon decided to end aquablation treatment due to the shifting of the prostate in sagittal ultrasound view and misalignment to the original contour of the second treatment pass and to forgo any additional delays to the procedure as the surgeon was satisfied with the prostatic resection that had previously taken place.It was then observed that the urethra was impacted; a slight tear in the superficial mucosal lining of the urethra was found; however, the surgeon was unable to determine if the impact to the urethra was caused either by the patient bucking, during removal of the handpiece or with insertion of the resectoscope.On (b)(6) 2023 procept confirmed through the surgeon that the intervention that took place following the aquablation resection was that of the standard hemostasis protocol.The surgeon left the foley balloon catheter in proactively for 10 days.The patient was seen by the surgeon 1-2 days postoperatively and the foley balloon catheter was exchanged for a smaller size.Overall, the surgeon confirmed that the patient is doing well.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the treatment log files, device history record (dhr), and labeling.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.A review of the device history record (dhr) ab2000-b/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.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: contraindications: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: anesthesia risk.The reported event is unrelated to any alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the aquabeam robotic system.Based on the event details plus a review of the treatment 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065
• MDR Report Key: 16950431
• MDR Text Key: 315439296
• Report Number: 3012977056-2023-00071
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20211014C
• 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: 06/28/2023

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
• Device Lot Number: 21C01646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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