BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA SMARTXIDE TOUCH

    MDR report key: 19947156 · Received August 9, 2024

    Report

    Report Number
    3001431138-2024-00015
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 9, 2024
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    WE AS MANUFACTURER OF THE DEVICE HAVE PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION GATHERED BY THE US IMPORTER FROM THE CLINIC. A TECHNICIAN INSPECTED THE DEVICE IN DATE JULY THE 31ST, 2024. THE DEVICE WAS FOUND TO BE WORKING PROPERLY WITHOUT ANY ISSUE AND WITHIN SPECIFICATIONS. IN MORE DETAILS ALL THE MAIN COMPONENT THAT COULD HAVE BEEN INVOLVED IN THIS EVENT HAS BEEN INSPECTED AND TESTED BEFORE ANY SERVICE ACTIVITY. IN PARTICULAR FOOT PEDAL, DEVICE'S KEYS AND THE EMERGENCY STOP BUTTON HAS BEEN TESTED AND FOUND WORKING PROPERLY WITHIN SPECIFICATIONS. LASER EMISSIONS HAS BEEN FOUND TO BE WITHIN SPECIFICATIONS AND ALSO THE LASER SHUTTER HAS BEEN FOUND TO BE WORKING PROPERLY. AS A PRECAUTION THE FOOT PEDAL AND SHUTTER OF THE DEVICE HAS BEEN REPLACED WITH NEW ONES. DUE TO THE FACT THAT THE DEVICE WAS FOUND TO BE WORKING PROPERLY IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. IT IS SUPPOSED THAT AN INVOLUNTARY PRESSURE OF THE FOOT PEDAL CAUSED THE EVENT BUT IT CANNOT BE CONFIRMED. THE REPLACED FOOT PEDAL AND SHUTTER HAVE BEEN REQUESTED, DESPITE BEING FOUND CORRECTLY WORKING, TO BE SHIPPED BACK FOR ANALYSIS. IN CASE THE INVESTIGATION ON THESE COMPONENTS WILL CHANGE THE ROOT CAUSE OF THE EVENT, A DEDICATED FOLLOW-UP REPORT WILL BE PROMPTLY SUBMITTED WITH THE GATHERED INFORMATION. MOREOVER, THE EVENT IS MITIGATED IN ITS POTENTIAL RISK DUE TO THE FACT THAT THE EMISSION, WITH FAILURE OF THE FOOT-PEDAL CAN ONLY TOOK PLACE WITH THE DEVICE IN READY-MODE WHICH REQUIRED THE OPERATOR, PATIENT AND ALL OTHER PERSON PRESENT WITHIN THE DEVICE'S ROOM TO WEAR THE APPROPRIATE SAFETY GOGGLES. NO DESIGN DEFICIENCY HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT INSTEAD IS SUPPOSED THAT AN ERRONEOUS PRESSURE OF THE FOOT PEDAL COULD HAVE CONTRIBUTED TO THE EVENT. SPECIFICALLY, IT IS SUPPOSED THAT THE PHYSICIAN'S SHOES COULD HAVE STUCK IN THE FOOT PEDAL CAUSING THE UNWANTED LASER RADIATION (DUE TO FOOT PEDAL CONTINUOUS PRESSURE). NO CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA IS REQUIRED. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON JULY THE 26TH, 2024, EL. EN. ELECTRONIC ENGINEERING SPA RECEIVED A COMMUNICATION FROM THE US IMPORTER CUTTING EDGE LASER TECHNOLOGIES, OF A MALFUNCTION, WITH THE VETERINARY DEVICE SL040, IN WHICH THE CUSTOMER COMPLAINTS OF THE DEVICE DOUBLE PULSING AND FOOTSWITCH WORKING INTERMITTENTLY. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN SL040 LASER VETERINARY DEVICE (REF: M114A1, S/N: (B)(6) THAT IS MARKETED IN THE US. A SIMILAR MEDICAL DEVICE FOR HUMAN USE, DESPITE HAVING A DIFFERENT REF CODE AND BRAND NAME IS MARKETED IN THE US (REF: M110C1 - BRAND NAME: DEKA SMARTXIDE TOUCH) WITH 510(K) K133895. IN THE ABOVE-MENTIONED COMMUNICATION IS REPORTED THE FOLLOWING: THE VETERINARY CLINIC REPORTED TO THE US IMPORTER, CUTTING EDGE LASER TECHNOLOGIES THAT THE LASER CONTINUED TO EMIT, BURNED THE OR TABLE AND SINGED THE ANIMAL FUR. DURING THE EVENT NO PERSON GOT INJURED AND ALSO THE ANIMAL ONLY GOT THE FUR SINGED BUT WITHOUT ANY BURN/INJURY. THE EVENT TOOK PLACE WHILE THE VETERINARY WAS PERFORMING A SOFT TISSUE SURGERY AND WHILE STEPPED AWAY FROM THE DEVICE TO SUTURE THE LASER CONTINUED FIRING. IT IS REPORTED THAT VETERINARIAN WAS NOT ABLE TO TURN OFF THE DEVICE USING THE DEVICE'S KEY OR THE EMERGENCY BUTTON, SO THEY HAVE TO UNPLUG THE DEVICE. THE PRESENT EVENT HAS BEEN EVALUATED AS A REPORTABLE DUE TO THE FACT THAT THE EVENT REPRESENT AN ACCIDENTAL RADIATION OCCURRENCE (ARO) IN ACCORDANCE WITH FDA 21 CFR PART 1000-1040. ANYWAY, DUE TO THE FACT THAT A VERY SIMILAR DEVICE IS MARKETED IN THE US AS A MEDICAL DEVICE (WITH 510(K) K133895) WE, AS MANUFACTURER OF THE DEVICES, EVALUATED THIS EVENT TO BE ALSO REPORTABLE UNDER THE 21 CFR PART 803 AND PREPARED THE PRESENT REPORT (3500A). TO BE NOTED THAT IN THE PRESENT REPORT THE SUSPECT MEDICAL DEVICE INVOLVED IN THE EVENT IS REPORTED AS THE SIMILAR MEDICAL DEVICE DEKA SMARTXIDE TOUCH AND NOT THE ACTUAL VETERINARY DEVICE INVOLVED IN THE EVENT SL040.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635007 DEKA SMARTXIDE TOUCH DEKA SMARTXIDE TOUCH GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M114A1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown