BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 14432076 · Received May 18, 2022

    Report

    Report Number
    3012977056-2022-00059
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    January 25, 2021
    Report Date
    May 17, 2022
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B6142201011
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A REVIEW OF THE AQUABEAM ROBOTIC SYSTEM'S LOG FILE COULD NOT BE CONDUCTED AS THE DATE WHEN THE AQUABLATION PROCEDURE TOOK PLACE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(4) 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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. AQUABEAM ROBOTIC SYSTEM USER MANUAL, (B)(4), WAS REVIEWED AND STATES THE FOLLOWING: 4.2 PRECAUTIONS: NO CLAIM IS MADE THAT THE AQUABEAM ROBOTIC SYSTEM WILL CURE ANY MEDICAL CONDITION OR ENTIRELY ELIMINATE THE DISEASED ENTITY. REPEATED TREATMENT OR ALTERNATIVE THERAPIES MAY SOMETIMES BE REQUIRED. A HISTORICAL REVIEW FOR SIMILAR COMPLAINTS CONFIRMED TWO (2) COMPLAINTS OF DECREASED URINARY FLOW HAVE BEEN REPORTED TO PROCEPT BIOROBOTICS, WHICH INCLUDES THIS EVENT. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. NO CLAIM IS MADE THAT THE AQUABEAM ROBOTIC SYSTEM WILL CURE ANY MEDICAL CONDITION OR ENTIRELY ELIMINATE THE DISEASE IN THE DEVICE LABELING. NO DEVICE MALFUNCTION WAS REPORTED OR CONFIRMED THROUGH THE INVESTIGATION PERFORMED BY PROCEPT. 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

    ON (B)(6) 2022, PROCEPT BIOROBOTICS CORPORATION BECAME AWARE OF AN ARTICLE PUBLISHED ON 25-JAN-2021 IN THE INVESTIGATE AND CLINICAL UROLOGY (ICUROLOGY) THAT INCLUDED DETAILS OF 14 ADVERSE EVENTS REPORTED IN PATIENTS WITHIN 90 DAYS OF UNDERGOING AN AQUABLATION PROCEDURE. MOST PROCEDURAL-RELATED ADVERSE EVENTS WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 1 OR GRADE 2. THIS EVENT IS BEING SUBMITTED FOR ONE (1) OF TWO (2) EVENTS CLASSIFIED AS CLAVIEN-DINDO 3A DUE TO DECREASED URINARY FLOW (LUTS) EVALUATED BY CYSTOSCOPY. NO GRADE 4B OR GRADE 5 COMPLICATIONS WERE NOTED. NO DEVICE MALFUNCTION WAS REPORTED DURING THESE PROCEDURES. PER THE MANUFACTURER'S USER MANUAL, NO CLAIM IS MADE THAT THE AQUABEAM ROBOTIC SYSTEM WILL CURE ANY MEDICAL CONDITION OR ENTIRELY ELIMINATE THE DISEASED ENTITY. REPEATED TREATMENT OR ALTERNATIVE THERAPIES MAY SOMETIMES BE REQUIRED. ALL PERTAINING INFORMATION AVAILABLE TO PROCEPT BIOROBOTIC IS BEING SUBMITTED WITH THIS REPORT. THIS IS REPORT 11 OF 13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605107 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B6142201011

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention