BEUDAMED
    FDA Adverse Event Other Summary report: N

    900Z LASER

    MDR report key: 43856 · Received October 15, 1996

    Report

    Report Number
    2914019-1996-00009
    Event Type
    Other
    Date Received
    October 15, 1996
    Date of Event
    May 21, 1996
    Report Date
    October 15, 1996
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    HQF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE LASER BEGAN TO LOSE POWER (AS INDICATED ON CONSOLE DISPLAY). IT APPEARED AS THOUGH THE POWER DROPPED FROM 250 MW TO 100 MW THEN TO 25 MW. THE TECH AT THE CONSOLE INCREASED THE POWER ATTEMPTING TO CORRECT, EVEN THOUGH THE DR WAS STILL GETTING EXPECTED RESULTS. THE RESULTS OF CO'S SERVICE CALLL FOUND THAT A PCB MALFUNCTIONED AND CAUSED THE DISPLAY TO INDICATE A DROP IN POWER, WHEN IN REALITY THERE WAS NO DROP IN POWER. THE DR HAD TO STOP BLEEDING, BUT PROCEEDED WITH SURGERY. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 900Z LASER OPHTHALMIC LASER HQF COHERENT MEDICAL GROUP SYSTEM 900Z LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other