BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA SYSTEM

    MDR report key: 17533566 · Received August 12, 2023

    Report

    Report Number
    MW5140470
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    May 2, 2022
    Manufacturer
    UROLOGIX LLC
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CALLER REPORTED EVENT INVOLVING PROSTIVA SYSTEM. BEFORE STARTING A PROCEDURE, THEY WERE GOING TO PLUG IN THE MACHINE AND THE CONNECTION PIECE BROKE OFF INSIDE OF THE MACHINE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784861 PROSTIVA SYSTEM ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI UROLOGIX LLC PROSTIVA SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown