BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18922867 · Received March 18, 2024

    Report

    Report Number
    3012977056-2024-00066
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    January 2, 2024
    Report Date
    March 18, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS THE LOT NUMBER OF THE AB2000 SYSTEM IS UNKNOWN. 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: URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE PATIENT HAS AN ADHESION, ESSENTIALLY THE FLUFFY TISSUE STICKING TOGETHER LIKE VELCRO. THE TREATING SURGEON TRIED TO ADDRESS IT BY OPENING IT WITH A WIRE AND WAS WERE UNSUCCESSFUL. THE PATIENT WOULD NEED TO GO FOR AN OUTPATIENT PROCEDURE TO OPEN UP THE AREA. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE LIST URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE AS A POTENTIAL RISKS OF THE AQUABLATION PROCEDURE. BASED ON THE EVENT DETAILS PLUS A REVIEW OF THE 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 · 0

    ROOT CAUSE OF REPORTED EVENT HAS NOT 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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    ON (B)(6)2024, IT WAS REPORTED THAT A MALE PATIENT HAD UNDERGONE AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) SEVEN WEEKS PRIOR. PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT AFTER THE AQUABLATION PROCEDURE, THE PATIENT EXPERIENCED RELIEF FOR ABOUT TWO WEEKS. DURING THE SIX-WEEK FOLLOW-UP, THE PHYSICIAN PERFORMED CYSTOSCOPY, WHICH REVEALED OBSTRUCTION. THE PHYSICIAN ATTEMPTED TO RELIEVE IT WITH A WIRE BUT SUGGESTED AN OUTPATIENT PROCEDURE. NO MALFUNCTIONS OF THE AQUABEAM ROBOTIC SYSTEM WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185323 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other