BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED LASER SURGICAL INSTRUMENT

    MDR report key: 15198135 · Received August 10, 2022

    Report

    Report Number
    15198135
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 15, 2022
    Manufacturer
    ELLEX MEDICAL PTY. LTD.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ONCE PATIENT WAS POSITIONED FOR A YAG LASER CAPSULOTOMY PROCEDURE, IT WAS DISCOVERED THAT THE LASER GUIDANCE RED LIGHT WAS NOT WORKING. WITHOUT A RED DOT, THE PHYSICIAN DOES NOT KNOW WHERE THE LASER BEAM IS GOING. PHYSICIAN CANCELLED THE CASE AND WILL RESCHEDULE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457839 POWERED LASER SURGICAL INSTRUMENT GEX ELLEX MEDICAL PTY. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Unknown