BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 20141410 · Received September 4, 2024

    Report

    Report Number
    3012977056-2024-00218
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 3, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B6142101011
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    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 INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AQUABEAM ROBOTIC SYSTEM 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: 4.3. WARNINGS: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: SEXUAL DYSFUNCTION, INCLUDING EJACULATORY AND ERECTILE DYSFUNCTION. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE LIST EJACULATORY DYSFUNCTION AND INCONTINENCE OR OVERACTIVE BLADDER AS POTENTIAL RISKS OF AQUABLATION THERAPY. BASED ON THE EVENT DETAILS PLUS A REVIEW OF THE DHR AND IFU, 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.

    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 IS EXPERIENCING SEXUAL DYSFUNCTION. THE INITIAL REPORTER (CONSUMER) ENDED THEIR PHONE CALL WITH THE PROCEPT BIOROBOTICS CORPORATION REPRESENTATIVE BEFORE ANY ADDITIONAL DETAILS COULD BE OBTAINED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341754 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B6142101011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other