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); Hyponatremia (4494); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/11/2023

Event Type  Injury  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that following the aquablation procedure and prior to discharge, the patient received a one-unit blood transfusion.It was also reported that the patient exhibited signs of transurethral resection (tur) syndrome and hyponatremia.The patient was reported to be doing well and was discharged home.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

H6 : adverse event problem.Health effect clinical code 4581 - transurethral resection (tur) syndrome = a complication of a transurethral resection of the prostate procedure.It occurs as a consequence of the absorption of the fluids used to irrigate the bladder during the operation into the prostatic venous sinuses.Symptoms may include hyponatremia.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 currently in the possession of the user facility.The investigation of this event consisted of a review of the treatment logs, device history record (dhr) and labeling.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 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.Section 8.32 states the following: a.After the aquabeam handpiece removal, follow the standard clot evacuation procedure to remove clots and tissue with a cystoscopic sheath by using an ellik bladder evacuator or toomey syringe.B.Use one of the following methods to achieve hemostasis: · cautery followed by foley balloon catheter insertion.· under spinal anesthesia, insert a balloon catheter in the bladder with bladder neck traction then fill the bladder with sterile saline and maintain for approximately 30-60 minutes before starting cbi (continuous bladder irrigation) · balloon catheter in bladder with bladder neck traction · balloon catheter in prostatic fossa: - inflate balloon with 5cc in the bladder - under trus guidance retract balloon into prostatic fossa - inflate balloon to 30-50% of initial prostate volume - apply mild traction on the catheter to hold the balloon catheter in place · balloon catheter in bladder, no traction c.Start cbi per hospital protocol.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The treating surgeon confirmed that the aquabeam robotic system functioned as intended, and assessed the event to be related to the procedure.The aquabeam robotic system's ifu lists bleeding as a potential risk of the aquablation procedure.Based on the review of the treatment logs, 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 drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134 ; 6502327291
• MDR Report Key: 17887263
• MDR Text Key: 325122612
• Report Number: 3012977056-2023-00160
• Device Sequence Number: 1
• Product Code: PZP
• 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: 11/20/2023

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: 09/13/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• 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; Hospitalization
• Patient Sex: Male