BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 19944254 · Received August 8, 2024

    Report

    Report Number
    3012977056-2024-00200
    Event Type
    Death
    Date Received
    August 8, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 30, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE OF THE 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.

    Additional Manufacturer Narrative · 0

    PROCEPT ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, THE HOSPITAL DECLINED TO PROVIDE ANY FURTHER DETAILS. H.11 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). THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. 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: 3. CONTRAINDICATIONS: DO NOT USE THE AQUABEAM ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM'S INTENDED USE. 4.3. WARNINGS: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: O EMBOLISM. IT WAS REPORTED THAT DURING THE SECOND TREATMENT PASS, THE PATIENT, WHO HAD A HISTORY OF PULMONARY EMBOLISM, CODED AND WAS UNABLE TO BE RESUSCITATED. THE TREATING SURGEON REPORTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO AQUABLATION THERAPY. BASED ON THE INFORMATION OBTAINED THROUGH THE TREATING SURGEON, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND LABELING, THE EVENT IS CONSIDERED NOT 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 AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING THE SECOND TREATMENT PASS, THE PATIENT CODED AND WAS UNABLE TO BE RESUSCITATED. WHILE ATTEMPTING TO RESUSCITATE THE PATIENT, A LARGE MASS WAS NOTED VIA ULTRASOUND IN ONE OF HIS HEART VALVES THAT COULD NOT PASS. THE TREATING SURGEON BELIEVES THAT A MASS OF THAT SIZE WAS NOT DUE TO THE PROSTATE TREATMENT. IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF PULMONARY EMBOLISM. THE TREATING SURGEON REPORTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO AQUABLATION THERAPY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026505 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death