BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX

    MDR report key: 6218138 · Received January 3, 2017

    Report

    Report Number
    6218138
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    December 6, 2016
    Report Date
    December 20, 2016
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A CYSTOSCOPY; LEFT URETEROSCOPY LASER LITHOTRIPSY; LEFT URETER STENT EXCHANGE; RETROGRADE PYELOGRAM; AND EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY. THE PROCEDURE WAS UNEVENTFUL FOR THE PATIENT. AN EMPLOYEE IN THE OR RECEIVED A FIRST DEGREE BURN (REPORTED AREA WAS "HER BELLY") WHEN THE TUBING "CRIMPED" OUTSIDE OF THE PATIENT AREA AND "BLEW." THE LASER REP NOTED THE CRIMPED TUBING AND THE AREA THAT "BLEW." THE EMPLOYEE WAS SENT FOR TREATMENT TO OCCUPATIONAL MEDICINE. THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3639 PROFLEX FIBER, LASER GEX INNOVAQUARTZ LLC #S-LLF273 25616-005

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR NO