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 Problems Fistula (1862); Perforation (2001); Urinary Tract Infection (2120); Insufficient Information (4580)

Event Date 01/24/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).On (b)(6) 2023, procept biorobotics corporation (procept) became aware that the patient reported to the treating surgeon feeling some bubbles when urinating once a week post aquablation therapy.The treating surgeon suspected an anal fistula.The treating surgeon sent all images taken during the aquablation procedure to a radiologist for review.The radiologist noticed a loss of fatty border between the upper part of the anal canal and the posterior face of the prostate, prior to the aquablation therapy.Once aquablation therapy started, a hypoechoic area appeared, erasing the fat, which was in contact with the posterior part of the treatment area.It was the radiologist opinion's that the prostate shell at this location seemed very thin and that the fistula, if existed, was probably there.It seems that this occurred prior to the waterjet resection and likely while inserting the trus probe.No further information was provided by the treating surgeon.No malfunction of the aquabeam robotic system was reported.On (b)(6) 2023, procept confirmed through the treating surgeon that the patient was traveling out of the country and was scheduled to undergo a cytoscan upon return.On (b)(6) 2023, procept confirmed through the treating surgeon that the patient reported almost no bubbles, which were already ruled as non-serious and rare, and a urinary tract infection.The patient is scheduled to see a different physician for consultation, but the overall urinary level was good.Procept is following up for more details regarding what was the original patient diagnosis and whether a medical intervention was required in this event.

Manufacturer Narrative

H.10 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

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 (b)(4) / 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: infection.A root cause for the reported event could not be determined.It was reported that the treating surgeon was unable to determine what may have occurred as the procedure was performed as usual and did not experience any unusual sensation while inserting the trus probe.The treating surgeon indicated that a ct scan was going to be conducted as a rectal perforation was suspected.The examination of the event log files by a procept clinical expert observed a lack of the fatty border between the upper section of the anal canal and the posterior aspect of the prostate that arose before the aquablation treatment, likely during the insertion of the trus probe, which may confirm the suspected rectal perforation as indicated by the treating surgeon.To date, although a scan was planned to investigate a potential rectal injury, no further details could be obtained by procept despite multiple follow-up attempts.The aquabeam robotic system instructions for use list rectal perforation and infection as a potential risks of the aquablation procedure.Based on the information received, plus a review of the event log file, ifu, and dhr, 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.

Manufacturer Narrative

H.10: additional information.On (b)(6) 2023, procept became aware that the cystoscan findings indicated the presence of a fistula between the colon and the anterior part of the bladder.The patient is being treated for fistula by the digestive department of the hospital.No malfunction of the aquabeam robotic system was reported and the event was determined to be unrelated to the aquablation procedure.

Manufacturer Narrative

H.6 : correction.Health effect - clinical code = 1862 - fistula.It was reported in the initial report that the treating surgeon suspected an anal fistula.Hence the code has been changed from 2001 - perforation to 1862 - fistula, as an anal fistula is not the same as rectal perforation.

• 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 CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065 ; 6502327291
• MDR Report Key: 16829568
• MDR Text Key: 314162375
• Report Number: 3012977056-2023-00059
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190328W
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 06/16/2023; 08/26/2023; 09/04/2023
• Supplement Dates FDA Received: 07/05/2023; 09/01/2023; 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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