BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER

    MDR report key: 14560 · Received June 13, 1994

    Report

    Report Number
    14560
    Event Type
    Injury
    Date Received
    June 13, 1994
    Date of Event
    June 9, 1994
    Report Date
    June 13, 1994
    Manufacturer
    HGM, INC.
    Product Code
    HQB
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE LASER WAS THEN USED TO APPLY PHOTOCOAGULATION TO THE PERIPHERY AS WELL AS TO BLEEDERS. AT THE START OF THE LASER THERE WAS A FIRST SHOT WITH SETTING ON 0.2 WATTS. THERE WAS AN INTENSE RETINAL BREAK WITH A RESULTANT RETINAL HOLE CREATED. THERE WERE TWO OTHER TIMES WHEN THE LASER APPEARED TO HAVE SURGES WHERE TWO OTHER SMALL RETINAL BREAKS WERE CREATED. LASER HAD MALFUNCTIONED CAUSING MULTIPLE RETINAL HOLES. THE EVENING PRIOR TO THE SURGERY, THE SVC REP DID PREVENTIVE MAINTENANCE ON THE MACHINE. THE MACHINE WAS NOT USED AFTER THIS SERVICING UNTIL THIS SURGERY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER LASER HQB HGM, INC. 8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention