BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE DOT

    MDR report key: 20076989 · Received August 27, 2024

    Report

    Report Number
    3001431138-2024-00016
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    June 30, 2024
    Report Date
    August 27, 2024
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K072159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    WE AS MANUFACTURER OF THE DEVICE INVOLVED IN THE EVENT PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION GATHERED BY OUR US IMPORTER (AND DISTRIBUTOR IN CHINESE TERRITORIES). THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED IN DATE JUNE THE 30TH, 2024 BY AUTHORIZED LOCAL SERVICE. THE TECHNICIAN FOUND THE SPRING THAT KEEP THE DEVICE'S ARTICULATED ARM UPRIGHT TO BE DETACHED FORM THE ARM ITSELF. THIS DETACHMENT TOOK PLACE DUE TO THE UNSCREW OF THE SET-SCREW THAT KEEP THE SPRING CONNECTED TO THE DEVICE'S ARTICULATED ARM. THE DEVICE HAS BEEN REPAIRED BY THE TECHNICIAN BY SCREWING BACK THE SET-SCREW IN ORDER TO ASSURE THAT IT WILL NOT GET UNSCREW IN THE FUTURE. THIS DESIGN OF THE ARTICULATED ARM/SPRING HAS BEEN CHANGED WITH A MORE RELIABLE ONE IN 2021. THE NEW DESIGN IS IN PLACE ON ALL THE DEVICE SINCE JANUARY THE 15TH, 2021. AN INVESTIGATION ON PREVIOUS SIMILAR CASES HAS BEEN PERFORMED IN ORDER TO ESTABLISH THE FREQUENCY OF SIMILAR EVENTS. UP TO DATE THE IS NO RECORD OF SIMILAR EVENT EVER HAPPENED IN THE LAST 5 YEAR (EXPECTED SERVICE LIFE) AGAINST APPROXIMATELY 7700 MEDICAL DEVICES INSTALLED WORLDWIDE SINCE 2003. BASED ON THIS DATA THE RELATIVE PROBABILITY OF THIS EVENT IS CALCULATED TO THE 0,01%. BASED ON THIS VERY LOW PROBABILITY AND THE FACT THAT THIS KIND OF ARM IS NO LONGER IN USE ON ANY OF THE DEVICES MANUFACTURED BY EL.EN. SPA, NO ACTION IS DEEMED NECESSARY ON THE DESIGN NOR THE INSTALLED DEVICES. IN FACT, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT (THERE IS NO EVIDENCE THAT LEAD TO A POSSIBLE CAUSE) AND THIS IS CONSIDERED AS A CASUAL EVENT. THIS REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAVE ANY QUESTIONS.

    Description of Event or Problem · 0

    IN DATE JULY THE 29TH, 2024 OUR US IMPORTER INFORMED US OF AN ADVERSE EVENT - THAT TOOK PLACE IN CHINA WHERE THEY DISTRIBUTE EL.EN.'S DEVICES - IN WHICH A PATIENT REPORTED A LESION DUE A DEVICE MALFUNCTION. IN THE NARRATIVE PROVIDED IT IS REPORTED THE FOLLOWING: IT IS REPORTED THAT A PATIENT REPORTED INJURIES NEAR THEIR EYES DUE TO THE DEVICE'S ARM FALLING INTO THEM DURING TREATMENT. PATIENT REQUIRED STITCHES AND MEDICAL INTERVENTION FOLLOWING THE EVENT. NO INFORMATION RELATIVE TO THE EVENT HAS BEEN DISCLOSED DESPITE THE ATTEMPTS. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN SERVICED IN DATE JUNE THE 30TH, 2024 DURING WHICH IT HAS BEEN REPAIRED. MORE DETAILS ON THE SERVICE INTERVENTION AND INVESTIGATION PERFORMED WILL BE REPORTED ON SECTION H11 OF THE PRESENT REPORT. THE PRESENT ADVERSE EVENT HAS BEEN EVALUATED AS A REPORTABLE, IN ACCORDANCE WITH US FDA 21 CFR PART 803 BECAUSE THE PATIENT REQUIRED MEDICAL ATTENTION FOLLOWING THE TREATMENT. MOREOVER THE US IMPORTER ALREADY SUBMITTED THE MDR REPORT (B)(4) FOR THIS EVENT AND WE, AS MANUFACTURER OF THE INVOLVED DEVICE, PROCEEDED TO SUBMIT THE PRESENT REPORT IN ORDER TO SUPPLY ALL THE MISSING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30069 DEKA SMARTXIDE DOT DEKA SMARTXIDE DOT GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M079S1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other