BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 11830775 · Received May 17, 2021

    Report

    Report Number
    3001431138-2021-00005
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 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. MOST OF THE INVESTIGATION HAS BEEN CARRIED OUT, AT FIRST, IN ORDER TO HAVE A CONFIRMATION ABOUT THE DIAGNOSIS OF THE PATIENT'S PATHOLOGY. IN FACT IT HAS BEEN CONFIRMED BY A HEALTH PROFESSIONAL BY THE USE OF CXR AND CT IN WHICH IT WAS IDENTIFIED AS A LARGE PERITONEUM. THE HEALTH PROFESSIONAL COMMENTED ALSO BY STATING THAT THE AMOUNT OF AIR PRESENT COULD NOT BE PRODUCED BY A BOWEL PERFORATION. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED BY CYNOSURE'S AUTHORIZED TECHNICIAN IN DATE APRIL THE 20TH, 2021, AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. PARTICULAR ATTENTION HAS BEEN PUT IN THE VERIFICATION OF THE AIR PUMP ON BOARD OF THE DEVICE AS WELL AS THE AMOUNT OF AIR THAT IT GENERATES AND EMITS. THE AIR FLOW HAS BEEN EVALUATED AND FOUNT IT WELL WITHIN NOMINAL VALUES. MOREOVER THE VAGINAL EXAM AND SIGMOIDOSCOPY BOTH HIGHLIGHTED THAT NO PERFORATION WERE PRESENT. THAT SAID IT IS IMPOSSIBLE THAT ARE COULD HAVE FLOWN FROM THE TREATED AREA TO THE ABDOMINAL CAVITY. 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 6TH, 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 TOLERATED THE PROCEDURE WITH MILD PAIN. SHE WAS MONITORED PER PROTOCOL AND AFTER 5 MINUTES COMPLAINS OF NOT FEELING WELL AND FEELING A LITTLE NAUSEATED. SHE WAS PLACED IN SUPINE POSITION. VITAL SIGNS WERE STABLE AND SHE BEGAN TO COMPLAIN OF EPIGASTRIC, CHEST PAIN/CHEST TIGHTNESS RADIATING INTO BOTH ARMS. 911 PARAMEDICS WERE CALLED THEY DID EKG WHICH WAS NORMAL AND ORTHOSTATIC WHICH WERE NORMAL. PATIENT HAD NOT EATEN TODAY SO BLOOD SUGAR WAS PERFORMED WHICH WAS NORMAL AT 110. AFTER THEY ARRIVED, SHE BECAME MORE ANXIOUS AND HER REPEAT BLOOD PRESSURE BY THEM WAS NOTED TO BE 163/95, NORMAL ORTHOSTATIC. THEY DID NOT FEEL SHE WAS HAVING A CARDIAC ISSUE. SHE WAS TAKEN TO THE ER FOR FURTHER EVALUATION. SHE WAS A&OX3 (ALERTED AND ORIENTED, TIMES 3 - TO PERSON, PLACE AND TIME) AND SITTING UP IN WHEELCHAIR. ORIGINALLY REPORTED BY (B)(6) (SITE CONTACT OF THE CLINIC (B)(6) LOCATED AT (B)(6)) AS TOO MUCH CO2 IN THE BODY. PATIENT WAS TAKEN BY EMS TO ER AND VAGINAL EXAM UNDER ANESTHESIA SHOWED NO PERFORATION. FLEXIBLE SIGMOIDOSCOPY DONE TO R/O RECTAL PERFORATION - NEGATIVE ALSO. THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE2 MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4) 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 (B)(4) 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 (B)(4) IN DATE MAY THE 13TH, 2021 AS IMPORTER OF THE DEVICE. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON MAY THE 6TH, 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
    734553 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other