BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 16693519 · Received April 6, 2023

    Report

    Report Number
    3012977056-2023-00044
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 6, 2023
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY INPROCESS. ADVERSE EVENT PROBLEM. COMPONENT CODE 4756: PER THE INSTRUCTIONS FOR USE, THE AQUABEAM MOTORPACK, A RE-USABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, PROVIDES POWER TO THE AQUABEAM HANDPIECE BY MEANS OF DC MOTORS. DEVICE EVALUATION BY MANUFACTURER. THE AQUABEAM MOTORPACK WAS RETURNED FOR INVESTIGATION. FUNCTIONAL TESTING AND ADDITIONAL ANALYSIS WERE ABLE TO CONFIRM THE REPORTED EVENT AS THE MOTORPACK WAS INOPERABLE AND EVIDENCE OF FLUID INGRESS WAS OBSERVED. FURTHER INSPECTION SHOWS AN ELECTRICAL SHORT OCCURRED ON ONE OF THE CONNECTORS OF THE SUBASSEMBLY CABLE LIKELY CAUSED BY FLUID. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AQUABEAM ROBOTIC SYSTEM/SERIAL NUMBER (B)(4) AND THE AQUABEAM MOTORPACK / LOT NUMBER 22C01097 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 AND ITS ASSOCIATED COMPONENT MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE CURRENT USER MANUAL UM0101-00 REV. F, AQUABEAM ROBOTIC SYSTEM USER MANUAL, US, ENGLISH AMD IFU0101-00, AQUABEAM ROBOTIC SYSTEM IFU, US, ENGLISH WERE REVIEWED. UM0101-00 REV. F SECTION 11.2.7 STERILE: MOTORPACK DRAPING AND DOCKING WITH THE AQUABEAM HANDPIECE DRAPE THE MOTORPACK WITH DEROYAL CAMERA DRAPE (REF (B)(4) OR EQUIVALENT) SO THAT A TIGHT SEAL IS FORMED AROUND THE RECESS AREA WHERE THE AQUABEAM HANDPIECE WILL ATTACH TO: PRE-STRETCH THE ELASTIC REGION TO REDUCE RISK OF TEARS WHEN SEATING IT IN RECESS OF THE MOTORPACK. ENSURE THE DRAPE IS PROPERLY SEATED IN RECESS OF THE MOTORPACK. ENSURE THE DRAPE IS NOT OBSTRUCTING THE MAGNETIC PLATE ON THE MOTORPACK. CAUTION: PULL THE DRAPE BACK TO RECESS OF THE MOTORPACK. WARNING: TO AVOID POTENTIAL CONTAMINATION OF THE MOTORPACK, ENSURE IT IS DRAPED WITH A NEW STERILE DRAPE FOR EACH PROCEDURE. IFU0101 REV. E AQUABEAM ROBOTIC SYSTEM STATES THE FOLLOWING: SECTION 8.8: STERILE: DOCK THE MOTORPACK TO THE AQUABEAM HANDPIECE AND APPLY STERILE TAPE OVER THE CONNECTION BETWEEN THE AQUABEAM HANDPIECE AND THE MOTORPACK TO SEAL IT. DO NOT APPLY STERILE TAPE OVER THE AQUABEAM SCOPE. KEEP THE MOTORPACK AND THE AQUABEAM HANDPIECE ASSEMBLY WITH THE AQUABEAM SCOPE CLAMP ASSEMBLY IN A SECURE AND STERILE ENVIRONMENT. REFER TO USER MANUAL FOR DETAILED MOTORPACK AND AQUABEAM HANDPIECE DOCKING AND DRAPING INSTRUCTIONS. THE ROOT CAUSE IS UNDETERMINABLE AS IT IS UNKNOWN HOW FLUID ENTERED THE MOTORPACK SHELL; HOWEVER, IT'S LIKELY FLUID ENTERED THROUGH THE ASSEMBLY CABLE OR THE COUPLERS. 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

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING THE AQUABLATION PROCEDURE, FLUID CREPT INTO THE AQUABEAM HANDPIECE AND TOWARD THE AQUABEAM MOTORPACK, DAMAGING THE MOTORPACK AND RENDERING IT INOPERABLE. AS A RESULT, THE AQUABLATION PROCEDURE WAS ABORTED, AND THE PROCEDURE WAS CONVERTED INTO AN UNSPECIFIED SURGICAL PROCEDURE. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED WITH THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020782 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male