BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINX JR.

    MDR report key: 9726703 · Received February 19, 2020

    Report

    Report Number
    9726703
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 23, 2020
    Manufacturer
    LISA LASER PRODUCTS GMBH
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SPHINX LASER WOULD NOT WORK. IT WAS TURNED ON AND DISPLAYED MULTIPLE WARNING SIGNS. REP WAS CALLED AND IT COULD BE RESOLVED AT THAT TIME. CASE WAS CANCELLED BECAUSE LASER WOULD NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189451 SPHINX JR. POWERED LASER SURGICAL INSTRUMENT GEX LISA LASER PRODUCTS GMBH SPHINX JR

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA