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

Model Number	AB2000C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation procedure the patient was taken back to the operating room (or) for clot evacuation and fulguration.The patient's hemoglobin (hb) level was 130 g/dl, with no bleeding vessels, and was discharged home the next day.No malfunction of the aquabeam robotic system was reported.
Additional 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 device history record (dhr), and labeling.A review of the device history record (dhr) ab2000-c/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.A root cause for the reported event could not be determined.It was reported that post-op, the patient was taken back to the operating room for clot evacuation and fulguration.The aquabeam robotic system instructions for use list bleeding as a potential risk of the aquablation procedure and provide adequate instructions on how to achieve appropriate hemostasis.Based on the review of the information provided, plus a review of the dhr and ifu this 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
• Common Device Name: 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: 17288558
• Report Number: 3012977056-2023-00113
• Device Sequence Number: 12426718
• Product Code: PZP
• UDI-Device Identifier: B614AB2000C1
• UDI-Public: +B614AB2000C1/16D20220330O
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: AB2000C
• Device Catalogue Number: AB2000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male