BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 12029246 · Received June 18, 2021

    Report

    Report Number
    3012977056-2021-00042
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    June 8, 2021
    Report Date
    January 13, 2022
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 ADDITIONAL MANUFACTURER NARRATIVE: THE AQUABEAM ROBOTIC SYSTEM WAS NOT RETURNED AND IT IS CURRENTLY IN USE AT THE USER FACILITY. THE INVESTIGATION OF THIS EVENT IS BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE DEVICE HISTORY RECORD, IFU, AND SIMILAR COMPLAINTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B REV. G/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. 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: BLEEDING. A REVIEW FOR SIMILAR COMPLAINTS UNDER AB2000-B REV. G/SERIAL NUMBER: (B)(6) CONFIRMED NO OTHER SIMILAR EVENTS REPORTED TO PROCEPT BIOROBOTICS. A REVIEW FOR SIMILAR COMPLAINTS ACROSS ALL SYSTEMS CONFIRMED 27 SIMILAR EVENTS. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS BLEEDING AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. BASED ON THE INFORMATION RECEIVED PLUS 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.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY INPROCESS. 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 · 1

    MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT POST-AQUABLATION PROCEDURE THE PATIENT RETURNED TO THE OPERATING ROOM DUE TO BLEEDING (PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, BLEEDING LISTED AS A PERIOPERATIVE RISK OF THE AQUABLATION). THE BLEEDING WAS ATTRIBUTED TO REMNANT PROSTATIC TISSUE, WHICH WAS ADDRESSED BY PERFORMING A RESECTION OF THE PROSTATE (TURP) SURGICAL PROCEDURE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921099 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention