BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLIM E30 MIXTO

    MDR report key: 2596784 · Received November 30, 2010

    Report

    Report Number
    3004710757-2010-00001
    Event Type
    Other
    Date Received
    November 30, 2010
    Date of Event
    August 27, 2010
    Report Date
    November 24, 2010
    Manufacturer
    LASERING S.R.L.
    Product Code
    GEX
    PMA / PMN Number
    K063001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRST INCIDENT REPORT OF THIS PROBLEM. CONCLUSION AFTER INVESTIGATION: ISOLATED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT/PROBLEM, WAS FIRST BROUGHT TO OUR ATTENTION ON (B)(4) 2010, BY (B)(6) OF (B)(6). THE SCANNER ON THE SLIM E30 CO2 LASER, USED FOR SKIN RESURFACING, STOPPED SCANNING AND THE PT RECEIVED AN INDUCED ABLATION SPOT OF ABOUT 300 MICRONS IN DIAMETER ON THE UPPER LIP. THE EXPOSURE TIME WAS ESTIMATED TO BE ABOUT 2.5 MS. WHEN THE SCANNER STOPPED, THE SCANNER ALARM WAS ACTIVATED AND THE LASER WAS RENDERED INOPERABLE. A SERVICE TECH INVESTIGATED THE PROBLEM. HE WAS ABLE TO DUPLICATE THE PROBLEM. AS A CORRECTIVE ACTION, HE DISCONNECTED AND INSPECTED ALL CONNECTORS (INTERNAL AND EXTERNAL) RELATED TO THE SCANNER. OBSERVED NO VISIBLE SIGN OF FAILURE OR DAMAGE AND RECONNECTED ALL CONNECTORS. TESTED LASER IN USER MODE FOR 1.5 HOURS. COULD NOT DUPLICATE THE PROBLEM. (B)(6), QUALITY MGR AT (B)(6), WAS CONTACTED ON (B)(4) 2010 ((B)(6)). SHE STATED "THERE WAS NO PERMANENT HARM TO THE PT AND THE SPOT HEALED WELL. NO FURTHER INTERVENTION WAS PLANNED. THEY DID NOT REPORT THE INCIDENT TO THE FDA BECAUSE THERE WAS NO PERMANENT INJURY TO THE PT AND CONSIDERED THE CASE CLOSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIM E30 MIXTO CO2 SURGICAL LASER GEX LASERING S.R.L. SLIM E30 MIXTO NA

    Patients

    Seq Age Sex Outcome Treatment
    1