BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 12112696 · Received July 2, 2021

    Report

    Report Number
    3012977056-2021-00043
    Event Type
    Death
    Date Received
    July 2, 2021
    Date of Event
    June 7, 2021
    Report Date
    October 20, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 ADDITIONAL MANUFACTURER NARRATIVE: THE AQUABEAM ROBOTIC SYSTEM'S LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE. THE REVIEW OF THE LOG FILE INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6) WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, 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. A REVIEW FOR SIMILAR COMPLAINTS CONFIRMED SIX (6) EVENTS HAVE BEEN REPORTED TO PROCEPT BIOROBOTICS. THE AQUABEAM ROBOTIC SYSTEM'S 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: O BLEEDING. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE, IFU0101-00, WARNS OF POTENTIAL PERIOPERATIVE RISKS ASSOCIATED WITH THE AQUABLATION PROCEDURE, INCLUDING BLEEDING, HOWEVER, THIS EVENT EVENT WAS UNLIKELY RELATED TO THE AQUABLATION PROCEDURE, BASED UPON THE OPINION OF THE TREATING PHYSICIAN. THE PATIENT WAS TRANSFUSED, WHICH WAS RELATED TO SURGERY DUE TO THE AQUABLATION PROCEDURE; HOWEVER, THE REST OF COMPLICATIONS WERE UNRELATED. PATIENT'S HEMOGLOBIN LEVELS WERE IN NORMAL RANGE POST TRANSFUSION. BASED ON THE REVIEW OF THE LOG FILE, DHR, AND THE INFORMATION FROM THE TREATING PHYSICIAN, IT IS CONCLUDED THAT 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.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY INPROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT THE AQUABLATION PROCEDURE WAS STOPPED, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2021, PROCEPT BECAME AWARE THAT THE PATIENT HAD PASSED AWAY. THE TREATING PHYSICIAN REPORTED THAT THE PATIENT HAD CARDIAC ISSUES (SPECIFIC DETAIL OF ISSUES WERE NOT PROVIDED) AND THAT THE PATIENT HAD BEEN ADMINISTERED A BLOOD TRANSFUSION. FOLLOWING THE BLOOD TRANSFUSION, THE PATIENT'S HEMOGLOBIN LEVELS WENT FROM APPROXIMATELY 14 G/DL TO 12 G/DL OVERNIGHT. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED TO PROCEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004348 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death