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 Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 01/05/2024

Event Type  Injury  

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.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the first treatment pass, the patient began to move, but not significantly.The treating surgeon decided to stop the treatment and allowed anesthesia to administer additional paralytics to further relax the patient, who was already intubated under general anesthesia.The aquablation procedure was resumed after a couple of minutes without any issues.The patient was highly vascular, and significant tissue was removed during hemostasis to identify and cauterize sources of bleeding post-aquablation procedure.The treating surgeon observed bleeding from large sinuses of the prostate, particularly in the high lateral and anterior areas.Concerns grew regarding blood loss, as the patient became hypotensive, and core body temperature lowered, which was suspected to be due to the volume of room-temperature saline fluids during hemostasis.The patient required two units of blood transfusion.Given the venous nature of the bleeding and the patient's condition, the treating surgeon attempted catheter insertion and traction to tamponade the venous bleeding.However, the bleeding persisted, with the catheter displaying a very dark red.Despite applying aggressive hemostasis, the bleeding continued, presenting with a light pink effluent.The treating surgeon revisited the area with the resectoscope, yielding the same outcome.Subsequently, the treating surgeon urgently contacted radiology for an emergency prostatic artery embolization (pae) as a deemed solution to control the persistent bleeding.The patient was reported to have experienced edema due to fluid volume.The urologist was consulted, who suggested that the treating surgeon may have inadvertently entered the dorsal vein and recommended applying pressure on the prostate trans-rectally to tamponade the bleeding.Fingers were introduced for pressure application, while the aquabeam trus arm and probe were set up for tamponade.Upon trus reintroduction, it was noticed that the foley balloon catheter was not in the bladder but rather in the prostatic fossa (with 60cc).The foley balloon catheter was repositioned into the bladder, and additional water (100cc) was added to prevent slipping into the fossa.It was suspected that the catheter was either not fully placed into the bladder due to anatomical length or that the open bladder neck pulled it back into the fossa.Following proper foley balloon catheter placement, and tamponade application with the trus probe, the catheter cleared.Over the next 15-20 minutes, the bleeding stabilized, and the tamponade from the trus was removed to monitor the bleeding status.The catheter remained clear, and the decision for pae was waived.Instead, the patient was transferred to the icu with continuous bladder irrigation (cbi) traction, and lasix was administered as much as possible.The patient is reported to be doing well and has been discharged.No malfunctions of the aquabeam robotic system were reported.

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.A review of the device history record (dhr) for ab2000-b/serial number (b)(6) was performed, 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 device met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use 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.A root cause for the reported event could not be determined.It was reported that the patient was highly vascular, and significant tissue was removed during hemostasis to identify and cauterize sources of bleeding, post-aquablation procedure.The urologist who was consulted, suggested that the treating surgeon may have inadvertently entered the dorsal vein and recommended applying pressure on the prostate trans-rectally to tamponade the bleeding.Fingers were introduced for pressure application, while the aquabeam trus arm and probe were set up for tamponade.Upon trus reintroduction, it was noticed that the foley balloon catheter was not in the bladder but rather in the prostatic fossa (with 60cc).Following proper foley balloon catheter placement, and tamponade application with the trus probe, the catheter cleared.The aquabeam robotic system's ifu lists bleeding as a potential risk of the aquablation procedure.Based on the 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; 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: 18627407
• MDR Text Key: 334367207
• Report Number: 3012977056-2024-00018
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190308T
• 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: 03/04/2024

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: 01/06/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2019
• 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