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

Catalog Number AB2000

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

Patient Problem Perforation (2001)

Event Date 12/05/2023

Event Type  Injury  

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 prostate appeared very small, with a high bladder neck, and no evidence of the waterjet undermining the bladder neck was observed.The system functioned as designed.A review of the device history record (dhr) for ab2000-b/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 met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0104-00, rev.C, was reviewed and states the following: 4.3.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include but are not limited to the following, some of which may lead to serious outcomes and may require intervention: o bladder or prostate capsule perforation.A root cause for the reported event could not be determined.The patient had a history of prostatitis before the aquablation procedure.No bladder neck undermining was detected after hp removal and the bladder neck appeared to be intact during focal bladder neck cautery (fbnc) technique.It is unclear whether the bladder neck was undermined during the aquablation procedure.The aquabeam robotic system instructions for use bladder or prostate capsule perforation as a potential risk of the aquablation procedure.Based on the event details plus a 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.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that the treating surgeon suspected bladder neck undermining.It was reported that the patient had prostatitis before the aquablation procedure.No bladder neck undermining was detected after the removal of the aquabeam handpiece, and the bladder neck appeared to be intact during the focal bladder neck cautery (fbnc) technique, achieving a good hemostatic outcome.It was reported that the trus probe was removed before fbnc was performed.Subsequently, the surgeon struggled to insert a catheter into the bladder.Multiple attempts were made using a guide wire and a smaller catheter but were unsuccessful.Upon inserting the resectoscope, the surgeon became aware of bladder neck undermining, which was managed with a suprapubic catheter employed after cautery.It remains unclear whether the undermining occurred during the aquablation procedure.The patient is reported to be doing well.No malfunction of the aquabeam robotic system was reported.

• 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 dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18387367
• MDR Text Key: 331290281
• Report Number: 3012977056-2023-00259
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221025K
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/22/2023

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2022
• 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): Required Intervention
• Patient Sex: Male