BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTXIDE CO2

    MDR report key: 5456446 · Received February 24, 2016

    Report

    Report Number
    3001431138-2016-00004
    Event Type
    Injury
    Date Received
    February 24, 2016
    Report Date
    February 24, 2016
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K072159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) CLINICAL INVESTIGATOR HAD REACHED OUT TO THE TREATMENT SITE AND WAS UNABLE TO GET ANY FOLLOW UP PATIENT INFORMATION OR DETAILS ABOUT THE EVENT. WITH MINIMAL INFORMATION COLLECTED, CLINICAL INVESTIGATOR WAS ABLE TO RECEIVE PHOTOS AND VIEW THE SCARRING ON PATIENT'S NECK REGION. CUSTOMER DID NOT ASK FOR CHECKING THE LASER AFTER THE EVENT. THEY ASKED JUST FOR CLINICAL ASSISTANCE WHICH THEY RECEIVED BY (B)(6). SERVICE CALL WAS OPENED ON (B)(6) REQUEST FOR ACTUAL DEVICE EVALUATION. A COMPLETE LASER CHECK-UP HAS BEEN PERFORMED BY (B)(6) SERVICE PERSONNEL ON JANUARY 22ND 2016 AT CUSTOMER SITE. THE (B)(6) SERVICE REPORT (B)(6) WAS GENERATED FOR THIS INCIDENT. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY OR DEVICE MALFUNCTIONING WAS RESPONSIBLE FOR CAUSING THE EVENT. RATHER, IT COULD BE ASSUMED THAT THERE WAS A HUMAN FACTORS ISSUE, WHERE A FAILURE TO APPROPRIATELY USE THE DEVICE, CONTRIBUTED TO EVENT. IT IS LIKELY THAT THE USER DID NOT APPLY THE LASER TREATMENT SETTINGS AS PER CLINICAL GUIDELINE. NO FAILURE DETECTED ON THE ACTUAL DEVICE EVALUATED. DEVICE WORKING WITHIN SPECS. NO REMEDIAL ACTIONS REQUIRED. EL.EN. ELECTRONIC ENGINEERING S.P.A., MANUFACTURER OF THE DEVICE, RECORDED ONLY ONE SIMILAR ADVERSE EVENT BEFORE, COMPARED WITH MORE THAN (B)(4) UNITS INSTALLED IN THE FIELD TO DATE AND TENS OF THOUSANDS OF TREATMENTS PERFORMED. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS. EVALUATION PERFORMED BY LOCAL SERVICE.

    Description of Event or Problem · 1

    NORTH AMERICA DISTRIBUTOR, (B)(6) LOCATED IN (B)(6), U.S., NOTICED US ABOUT AN ADVERSE EVENT RECENTLY THEY BECAME AWARE. INVOLVED DEVICE WAS SMARTXIDE MODEL CODE M079AC1, SN (B)(4), MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING S.P.A. - (B)(4). THE ACTUAL DATE OF EVENT IS UNKNOWN, BUT (B)(6) BECAME AWARE OF THIS INCIDENT ON (B)(6) 2016. EVENT TAKE PLACE IN (B)(6). (B)(6)'S CLINICAL INVESTIGATOR COLLECTED INFORMATION FROM CUSTOMER AND CONFIRMED US THAT A DEKA SMARTXIDE CO2 LASER WAS INVOLVED IN A CO2 LASER TREATMENT ON PATIENT (AGE, WEIGHT AND SEX ARE UNKNOWN) WHO DEVELOPED SCARRING IN TREATMENT REGION. (B)(6) CLINICAL INVESTIGATOR HAD REACHED OUT TO THE TREATMENT SITE AND WAS UNABLE TO GET ANY FOLLOW UP PATIENT INFORMATION OR MORE DETAILS ABOUT THE EVENT. WITH MINIMAL INFORMATION COLLECTED, CLINICAL INVESTIGATOR WAS ABLE TO RECEIVE PHOTOS AND VIEW THE SCARRING ON PATIENT'S NECK REGION. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JAN 27TH 2016 BY EMAIL FROM (B)(6) AND, ACCORDING TO 21 CFR PART 803, EL.EN. ELECTRONIC ENGINEERING S.P.A SUBMITTED TO FDA AN OWN INITIAL 30 DAYS MDR REPORT. THIS EVENT IS REPORTABLE TO FDA, ON THE SIDE OF CAUTION, BECAUSE THE INJURIES TO PATIENT (SCARS) HAVE BEEN CONSIDERED AS PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115552 SMARTXIDE CO2 DEKA SMARTXIDE CO2 WITH DOT SCANNER GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M079AC1

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability