BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18849557 · Received March 6, 2024

    Report

    Report Number
    3012977056-2024-00054
    Event Type
    Injury
    Date Received
    March 6, 2024
    Report Date
    March 6, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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) 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 (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. 8.32 STERILE: A. AFTER THE AFTER THE AQUABEAM AQUABEAM HANDPIECE REMOVAL, FOLLOW THE STANDARD CLOT HANDPIECE REMOVAL, FOLLOW THE STANDARD CLOT EVACUATION PROCEDURE TO REMOVE CLOTS AND TISSUE WITH A CYSTOSCOPIC EVACUATION PROCEDURE TO REMOVE CLOTS AND TISSUE WITH A CYSTOSCOPIC SHEATH BY USING AN ELLIK BLADDER EVACUATOR OR TOOMEY SYRINGE. 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 WAS TAKEN BACK TO THE OR FOR POST PROCEDURAL BLEEDING. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE LIST BLEEDING AS A POTENTIAL RISK 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 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.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT FOLLOWING THE AQUABLATION PROCEDURE, THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT DUE TO BLEEDING (ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS FOR USE, BLEEDING IS A PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). THE TREATING SURGEON DETERMINED THAT OPERATIVE TRANS-URETHRAL VISUALIZATION WAS NECESSARY FOR CONCERNS REGARDING HEMOSTASIS. THE PATIENT UNDERWENT AN IMMEDIATE ADDITIONAL PROCEDURE, WHICH PROVIDED ADEQUATE HEMOSTASIS. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED. IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2024 APPROXIMATELY. THERE WERE NO REPORTED MALFUNCTIONS OF THE AQUABEAM ROBOTIC SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137547 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention