BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11891339 · Received May 26, 2021

    Report

    Report Number
    3012977056-2021-00035
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    October 21, 2020
    Report Date
    June 17, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 ADDITIONAL MANUFACTURER NARRATIVE: THE AQUABEAM ROBOTIC SYSTEM'S LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE. THE REVIEW OF THE LOG FILE INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B REV. D/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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION.. A REVIEW OF SIMILAR COMPLAINTS WAS CONDUCTED ON AB2000-B REV. D/SERIAL NUMBER (B)(6), WHICH CONFIRMED NO SIMILAR EVENTS. A REVIEW OF SIMILAR COMPLAINTS ACROSS ALL OTHER SYSTEMS FOUND NO OTHER SIMILAR EVENTS. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED AND STATES THE FOLLOWING: WARNINGS: PROCEDURE. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE. INFECTION. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS INFECTION AND URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE AS POTENTIAL RISKS OF THE AQUABLATION PROCEDURE. NO FURTHER INFORMATION HAS BEEN ABLE TO BE OBTAINED REGARDING THIS EVENT. BASED ON THE REVIEW OF THE LOG FILE, 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.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE ON (B)(6) 2020 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). ON (B)(6) 2021, PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT THE PATIENT HAD A MEATAL STENOSIS (URETHRAL STRICTURE) FOLLOWING THE AQUABLATION PROCEDURE (PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, URETHRAL STRICTURE IS A POTENTIAL PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). ON (B)(6) 2021, THE PATIENT UNDERWENT A MEATOPLASTY, AND HAS MADE A FULL RECOVERY AND IS CURRENTLY DOING GOOD. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786986 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention