BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11942996 · Received June 4, 2021

    Report

    Report Number
    3012977056-2021-00040
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 1, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 ADDITIONAL MANUFACTURER NARRATIVE: ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT HOSPITALIZED FOR APPROXIMATELY TWO (2) WEEKS DUE TO VARIOUS REASON, SUCH AS ARRHYTHMIA, RULING OUT SEPSIS AND THE PATIENT HAVING DIFFICULTY SWALLOWING AND AMBULATING; BOTH COMMON IN ELDERLY PATIENTS WITH PROLONGED HOSPITAL STAYS. THE PATIENT WAS ADMITTED HOME AFTER THE EXTENDED HOSPITAL STAY AND IS NOW HOME. 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 B/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. A REVIEW FOR SIMILAR COMPLAINTS UNDER AB2000-B REV B/SERIAL NUMBER 19C00119 CONFIRMED NO OTHER SIMILAR EVENTS REPORTED TO PROCEPT BIOROBOTICS. 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: O BLEEDING. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS BLEEDING AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. THE ASSESSMENT BY THE TREATING PHYSICIAN ON THIS EVENT WAS THAT THE PATIENT WAS 90 YEARS OLD AND THAT WAS PART OF THE RISK FACTOR BASED ON HIS AGE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. 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. 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

    (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT POST-AQUABLATION PROCEDURE, THE PATIENT'S PROSTATIC CAVITY WAS EXTREMELY OOZY, CAUSING THE URINE PASSING THROUGH THE BALLOON CATHETER TO BE RED. THE TREATING PHYSICIAN INJECTED 100CC AND TENSION PLACED IN THE BALLOON BEFORE THE PATIENT WAS TAKEN INTO THE POST-ANESTHESIA CARE UNIT (PACU). THE PATIENT STOPPED BREATHING IN THE PACU BUT WAS RESUSCITATED WITHOUT INTUBATION. ULTIMATELY THE MEDICAL MANAGEMENT IN THE PACU CAME DOWN TO THE PATIENT BEING HYPOTENSIVE (LOW BLOOD PRESSURE) AND TWO (2) UNITS OF PACKED RED BLOOD CELLS (PRBCS) WERE ADMINISTERED. THE PATIENT'S HEMOGLOBIN LEVELS WERE APPROXIMATELY 10 G/DL WITH NO KNOWN PRE-OPERATIVE LEVELS. THE TRANSFUSION WAS ADMINISTERED DUE TO THE LOW BLOOD PRESSURE AND THE PATIENT BEING POSSIBLY UNDER HYPOVOLEMIC SHOCK. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR MEDICAL MANAGEMENT. THE ASSESSMENT BY THE TREATING PHYSICIAN ON THIS EVENT WAS THAT THE PATIENT WAS (B)(6) YEARS OLD AND THAT WAS PART OF THE RISK FACTOR BASED ON HIS AGE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839552 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R