BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8000231

    MDR report key: 14884862 · Received July 1, 2022

    Report

    Report Number
    14884862
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 13, 2022
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    UDI-DI
    00816469021346
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE WOULD NOT SCREW INTO MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549474 8000231 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC 8000231 DK21017 00816469021346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown