BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 20527557 · Received October 24, 2024

    Report

    Report Number
    3012977056-2024-00252
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 8, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427020
    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

    ON 24-OCT-2024, PROCEPT BIOROBOTICS CORPORATION (PROCEPT) RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS DISCHARGED IN "NORMAL CONDITION" DURING THE WEEK OF (B)(6) 2024.

    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

    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 DEVICE HISTORY RECORD (DHR) AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-D/SERIAL NUMBER: (B)(6) WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCE'S, 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'S 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. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE REPORTED EVENT IS UNRELATED TO ANY ALLEGED DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE AQUABEAM ROBOTIC SYSTEM. THE TREATING SURGEON REPORTED THAT THE PATIENT WAS A "VERY SICK PATIENT" PRIOR TO AQUABLATION THERAPY AND HAS UNSPECIFIED PRE-EXISTING CARDIAC ISSUES. THE TREATING SURGEON DOES NOT ATTRIBUTE THE EVENT TO AQUABLATION THERAPY. BASED ON THE EVENT DETAILS PLUS A REVIEW OF THE DHR AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE-RELATED.

    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 POST AQUABLATION THERAPY, THE PATIENT'S BLOOD PRESSURE DROPPED AND AS A RESULT, WAS ADMINISTERED MEDICATION. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT THE TREATING SURGEON DOES NOT ATTRIBUTE THE EVENT TO AQUABLATION THERAPY. THE PATIENT WAS REPORTED TO BE "VERY SICK" PRIOR TO TREATMENT AND HAS UNSPECIFIED PRE-EXISTING CARDIAC ISSUES. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790109 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H