BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 12023432 · Received June 18, 2021

    Report

    Report Number
    3001431138-2021-00009
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 17, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE, THE MANUFACTURER OF THE DEVICE, AND OUR US IMPORTER PERFORMED OUR INVESTIGATION BY CONTACTING THE SITE IN ORDER TO GATHER MORE DETAILED INFORMATION ABOUT THE EVENT. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED BY CYNOSURE'S AUTHORIZED TECHNICIAN IN DATE MAY THE 24TH, 2021 AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. ALL THE ENERGY EMISSION OF THE DEVICE HAS BEEN EVALUATED AND FOUND WELL WITHIN TOLERANCES. THE DEVICE'S AIR FILTER AND ACCESSORIES HAS BEEN EVALUATED AND FOUND WORKING PROPERLY WITHIN SPECIFICATIONS. BASED ON THE CLINICAL EVALUATION OF THE PATIENT AND THE EVALUATION OF THE DEVICE IT IS NOT POSSIBLE TO DETERMINE A CONNECTION BETWEEN THE ADVERSE EVENT AND THE USE OF THE DEVICE. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY OR DEVICE MALFUNCTIONING WAS RESPONSIBLE FOR CAUSING THE EVENT INSTEAD IS POSSIBLE TO CONCLUDE THAT THE ADVERSE EVENT IS NOT CONNECTED WITH THE DEVICE OR ITS USE. DEVICE WORKING WITHIN SPECIFICATIONS. NO REMEDIAL ACTION REQUIRED THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON MAY THE 26TH, 2021, EL.EN. ELECTRONIC ENGINEERING (B)(4) BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY US IMPORTER CYNOSURE, THAT RECEIVED A COMMUNICATION FROM THE CLINIC, CONCERNING AN ADVERSE EVENT HAPPENED TO A PATIENT FOLLOWING A MONALISA TOUCH TREATMENT WITH THE DEKA SMARTXIDE2 LASER MEDICAL DEVICE. THE US IMPORTER REPORTED TO US THE FOLLOWING INFORMATION, RELATIVE TO THE EVENT AND SUBSEQUENT EVALUATION OF THE PATIENT: THE PATIENT EXPERIENCED VAGINAL BLEEDING, ABDOMINAL PAIN, BLOATING AND CHEST PRESSURE FOLLOWING A MONALISA TOUCH TREATMENT WITH THE DEKA SMARTXIDE2 LASER MEDICAL DEVICE. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND PATIENT WAS THEN TAKEN TO THE EMERGENCY ROOM. A CHEST RAY WAS PERFORMED ON THE PATIENT SHOWING A SMALL PNEUMOTHORAX AND SOME AIR IN HER NECK. AN ABDOMINAL CT WAS ORDERED WITHOUT CONTRAST (DUE TO PATIENT'S ALLERGY). CT OF PELVIS WITH RECTAL CONTRAST FOUND NO ABDOMINAL PERFORATION. SPECULUM EXAM REVEALED A SMALL SUPERFICIAL TEAR IN THE VAGINAL MUCOSA NOT INVOLVING THE PERITONEUM. PELVISCOPY EXAM WAS PERFORMED AND GIVE NORMAL RESULTS. SOME GAS WAS FOUND ON THE OMENTUM. GASTRO-INTESTINAL TRACT, LIVER, DIAPHRAGM AND SPLEEN HAS BEEN EVALUATED AND FOUND NORMAL. PATIENT WAS THEN PLACED ON INTRA-VENOUS ANTIBIOTICS AND OBSERVED FOR THREE DAYS. PATIENT WAS THEN SENT HOME WITH NASAL O2 DUE TO PNEUMOTHORAX. ORIGINALLY REPORTED BY (B)(6) (SITE CONTACT OF THE CLINIC DR. (B)(6)). THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE2 MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE UNITED STATES WITH 510(K) NUMBER K133895. WE, THE MANUFACTURER OF THE DEVICE, RECEIVED THE INVESTIGATION PERFORMED BY THE US IMPORTER CYNOSURE INC. COMPANY LOCATED IN (B)(4), EVALUATING IT SATISFYING. CYNOSURE INC. ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. CYNOSURE INC. EVALUATED THE EVENT AS REPORTABLE BECAUSE THEY ASSUMED THE LESIONS TO BE A SERIOUS INJURY AND SUBMITTED ITS OWN MDR REPORT #MDR-1222993-2021-00018 IN (B)(6) 2021 AS IMPORTER OF THE DEVICE. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON MAY THE 26TH, 2021 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803.50(2), SUBMITTED TO FDA AN OWN MDR REPORT IN ORDER TO SUBMIT ADDITIONAL INFORMATION FORM THE REPORT SUBMITTED BY THE US IMPORTER. MOREOVER, WE EVALUATED THE EVENT REPORTABLE BECAUSE WE HAVE ASSUMED THE LESIONS TO BE A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925493 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention