BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TEN THOUSAND ENDODIODE LASER

    MDR report key: 165999 · Received April 30, 1998

    Report

    Report Number
    2028159-1998-00113
    Event Type
    Malfunction
    Date Received
    April 30, 1998
    Report Date
    April 2, 1998
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    H-10: DEVICE HAD BEEN DROPPED. A CO REP REPLACED CONTROL PCB AND CALIBRATED POWER SETTINGS. SYSTEM MET SPECS AND WAS RETURNED TO CUSTOMER. COMPONENT (SUSPECT DIODE) WAS SUBMITTED FOR FURTHER EVALUATION AND FOUND NOT TO BE DEFECTIVE. UNABLE TO REPRODUCE FAILURE DETECTED IN FIELD. SUSPECT DAMAGE TO SYSTEM CREATED HIGH RESISTANCE SHORT AND PRODUCED FAILURE MODE. FAILURE CONTINUED UNTIL THE COMPONENT WAS REMOVED AND REPLACED. DEVICE WAS SUBSEQUENTLY RECALLED. INTERNAL REFERENCE NUMBER CPA 130-98-071-CF. H-11: REVISED H7. THIS REPORT WAS MAILED IN TO FDA ON: 8/6/1998. THE MANUFACTURERS INTERNAL REFERENCE NUMBER IS: 4-11542-1-98.

    Description of Event or Problem · 1

    REPORTER NOTED CONTINUOUS FIRING IN READY MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TEN THOUSAND ENDODIODE LASER LASER PHOTOCOAGULATOR HQF ALCON LABORATORIES, INC. STT-EDL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA