BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11942997 · Received June 4, 2021

    Report

    Report Number
    3012977056-2021-00038
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 10, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: 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 OTHER SIMILAR EVENTS HAVE BEEN REPORTED TO PROCEPT. A REVIEW FOR SIMILAR COMPLAINTS ACROSS ALL OTHER SYSTEMS CONFIRMED FIVE (5) OTHER SIMILAR EVENTS. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), IFU (B)(4), REV. F, WAS REVIEWED AND STATES THE FOLLOWING: 4.3. WARNINGS: PROCEDURE AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: O URINARY RETENTION A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS URINARY RETENTION AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED ON THIS EVENT. BASED ON THE 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.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). ON (B)(6) 2021, DURING A VOICE OF CUSTOMER (VOC) INTERVIEW WITH THE TREATING PHYSICIAN, PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT THE PATIENT EXPERIENCED URINARY RETENTION POST-AQUABLATION PROCEDURE (PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, URINARY RETENTION IS A POTENTIAL PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). NO FURTHER INFORMATION REGARDING PATIENT'S CONDITION IS AVAILABLE AT THIS TIME OR WHETHER ANY ADDITIONAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839930 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other