BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 9450363 · Received December 11, 2019

    Report

    Report Number
    3001431138-2019-00013
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    October 15, 2019
    Report Date
    December 11, 2019
    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 RECEIVED THE INVESTIGATION PERFORMED BY THE US IMPORTER, CYNOSURE INC, IN WHICH IT IS STATED THAT THE PHYSICIAN MS. MARKI-DUNN (ASSOCIATES IN (B)(6)) CONTACTED THEM, VIA THEIR WEB-FORM, IN WHICH SHE STATED THAT ONE OF HER PATIENT REPORTED VAGINAL AGGLUTINATION FOLLOWING A MONALISA TOUCH TREATMENT IN A DEGREE IN WHICH HER CERVIX IS NO LONGER VISIBLE. THE PHYSICIAN SPECIFIED THAT HER PATIENT WAS NOT TREATED BY HER BUT FROM ANOTHER PHYSICIAN AND CLINIC. SHE HAVE BEEN CONTACTED BY THE US IMPORTER AND INFORMED THEM ABOUT THE PLACE WHERE HER PATIENT WAS TREATED WITH THE LASER BY DR. (B)(6) AT (B)(6). BASED ON THAT INFORMATION THE US IMPORTER IDENTIFIED THE DEVICE AND CONTACTED THE PHYSICIAN IN ORDER TO HAVE MORE DETAILED INFORMATION ON THE TREATMENT AND PATIENT. THE PHYSICIAN RESPONDED THAT HE HAS NO RECORD OF THE PATIENT AND DID NOT REMIND OF HER. ANYWAY HE HAVE NOT GOT ANY COMPLAINT FROM ANY PATIENT UP TO NOW. THE AGGLUTINATION REPORTED BY THE PATIENT CAN BE ASSUMED AS AN ABNOMAL CICATRIZATION/ADEHESION WHICH IS ONE OF THE FORESEEABLE SIDE EFFECT OF THE TREATMENT IDENTIFIED IN THE OPERATOR'S MANUAL CODE OM103P1_G.V05 (ACTUAL REVISION DELIVERED WITH THE DEVICE) AT CHAPTER 10.1.2 "SIDE EFFECTS". MOREOVER WE REQUESTED A CLINICAL EVALUATION OF THE AVAILABLE DATA TO DR. A. PIERALLI (GYNAECOLOGIST - DIRECTOR OF COLPOSCOPY AND LASER THERAPY DEPARTMENT AT (B)(6)) THAT HAVE CONFIRMED THAT, FOLLOWING TOO MUCH AGGRESSIVE OR ERRONEOUS TREATMENT, AGGLUTINATION IS A POSSIBLE SIDE EFFECT. THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED IN DATE NOVEMBER THE 15TH 2019 AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS (CYNOSURE'S SERVICE REPORT #(B)(4)). BASED ON THE INFORMATION GATHERED BY THE US IMPORTER WE, THE MANUFACTURE OF THE DEVICE, DID NOT HAVE ENOUGH EVIDENCES TO IDENTIFY THE ROOT CAUSE OF THE EVENT. ANYWAY, THE DEVICE IS WORKING PROPERLY SO NO REMEDIAL ACTION IS REQUIRED. MOREOVER THE OPERATOR'S MANUAL AND THE RISK MANAGEMENT FILE HAVE BEEN EVALUATED AND FOUND ADEQUATE. THIS INITIAL REPORT HAS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON NOVEMBER THE 12TH 2019, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER CYNOSURE INC., THAT RECEIVED A COMMUNICATION FROM THE CLINIC CONCERNING AN ADVERSE EVENT IN WHICH THE PATIENT DEVELOPED VAGINAL AGGLUTINATION FOLLOWING A MONALISA TOUCH TREATMENT. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE2. THE DEKA SMARTXIDE2 LASER MEDICAL DEVICE IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K133895. THE US IMPORTER CYNOSURE REPORTED THAT PHYSICIAN DR. ANALISA MARKI-DUNN CONTACTED CYNOSURE VIA THE WEBSITE COMPLAINING THAT ONE OF HER PATIENT SUFFEREND OF VAGINAL AGGLUTINATION AND HER CERVIX IS NO LONGER VISIBLE. MS. MARKI-DUNN REPORTED THAT THE PATIENT UNDERWENT A MONALISA TOUCH TREATMENT PREVIOUSLY WITH ANOTHER PHYSICIAN. WE, THE MANUFACTURER OF THE DEVICE, RECEIVED THE RESULTS OF THE INVESTIGATION OF OUR US IMPORTER CYNOSURE INC. COMPANY LOCATED IN (B)(6) FOR THIS CASE. 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 IT REPRESENT A SERIOUS INJURY AND SUBMITTED ITS OWN MDR REPORT #MDR-1222993-2019-00030 IN DATE NOVEMBER THE 14TH, 2019. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON NOVEMBER THE 12TH, 2019 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803.50(B)(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, ACCORDING TO FDA 21 CFR PART 803 THIS EVENT CONCERNS A SERIOUS INJURY IN WHICH THE PATIENT RECEIVED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249496 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other