BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEACON ADVANCED ENERGY CO2 LASER SYSTEM

    MDR report key: 10534650 · Received September 15, 2020

    Report

    Report Number
    10534650
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 25, 2020
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LASER TOUCH SCREEN HAS A DEAD SPOT ON THE LEFT-HAND SIDE. IT WILL NOT ALLOW YOU TO ACTIVATE ANY BUTTONS OR SETTINGS. OMNIGUIDE CONTACTED FOR REPAIRS, LOANER UNIT SHIPPED TO THE HOSPITAL. OUTPATIENT SURGERY, EXCISION LESION INTRAORAL LASER SCHEDULED. PATIENT PRESENTED TO PERIOPERATIVE SERVICES, PREOP ASSESSMENT COMPLETED, PERIPERHAL IV CATHETER PLACED, AND LACTATED RINGERS GIVEN. LOANER CO2 LASER (297326) WAS CHECKED PRIOR TO SURGERY. SURGICAL TECH WAS UNABLE TO GET THE SCREEN TO TURN ON, PASS CODE WOULD NOT WORK. SURGERY WAS CANCELED AND RESCHEDULED FOR FUTURE DATE. BIOMED IS WORKING WITH THE VENDOR REGARDING EQUIPMENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997946 BEACON ADVANCED ENERGY CO2 LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. 420060-AA

    Patients

    Seq Age Sex Outcome Treatment
    1