BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX

    MDR report key: 7768931 · Received August 9, 2018

    Report

    Report Number
    7768931
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 6, 2018
    Report Date
    July 6, 2018
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN NOTED A FOREIGN OBJECT IN THE KIDNEY. WHEN THE INSTRUMENTATION WAS REMOVED, IT WAS NOTED THAT THE TIP OF THE LASER FIBER WAS MISSING. THE PHYSICIAN WAS ABLE TO RETRIEVE THE MISSING PIECE OF A LASER FIBER. PATIENT HAD AN EXTENDED PERIOD OF SURGERY UNDER GENERAL ANESTHESIA, BUT NO PROBLEMS WERE NOTED. SHE WAS DISCHARGED HOME LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611185 PROFLEX POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC 13618003

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Other