BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX

    MDR report key: 7866428 · Received September 11, 2018

    Report

    Report Number
    7866428
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    July 25, 2018
    Report Date
    August 7, 2018
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING A URETEROSCOPY, LASERING A URETERAL STONE WITH THE HOLMIUM LASER FIBER 273, AND IT WAS NOTICED THAT THE TIP OF THE FIBER BROKE OFF INSIDE THE PATIENT. RETRIEVAL OF THE TIP WAS ATTEMPTED BUT SUCCESS OF RETRIEVAL WAS NOT VISUALIZED AS THE TIP IS CLEAR AND ONCE IT BROKE OFF IT IS HARD TO SEE THE TIP. COPIOUS AMOUNTS OF IRRIGATION WERE USED TO FLUSH THE TIP OUT. THE TIP WAS NOT VISUALIZED BEING FLUSHED OUT. IT IS NOT KNOWN IF THE TIP CAME OUT OR IS RETAINED. MANUFACTURER RESPONSE FOR HOLMIUM LASER FIBER PROFLEX 273, BARD PROFLEX 273 LASER LITHOTRIPSY FIBER (PER SITE REPORTER). A REP CAME ONSITE AND THEY ARE CHANGING THEIR PACKAGING SO THE TIP IS PROTECTED WITHIN THE PACKAGE WITHIN A PLASTIC PROTECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706770 PROFLEX POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC LSU273PF 02618005

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA