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); Urinary Retention (2119)

Event Date 02/27/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, a male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) was informed that the patient initially failed a voiding trial and needed a foley catheter during routine follow-up.After passing a subsequent voiding trial without complications, on (b)(6) 2024 the patient underwent emergent clot evacuation, fulguration, and ultimately transurethral resection of the prostate (turp).No malfunctions of the aquabeam robotic system were reported.

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

Correction: g2.Corrected to health professional.H11.Additional 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 log files, device history record (dhr), and instructions for use (ifu).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'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.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, urinary retention.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.The patient failed the initial voiding trial.Additionally, the patient was taken back to the operating room for emergent clot evacuation and fulguration.The aquabeam robotic system instructions for use list bleeding and urinary retention as potential risks of the aquablation procedure and provides adequate instructions on how to achieve appropriate hemostasis.Based on the review of the information provided, plus a review of the treatment log files, 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
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose 95134
• MDR Report Key: 19068539
• MDR Text Key: 339679199
• Report Number: 3012977056-2024-00104
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220627S
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 04/02/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2022
• 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