BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA SMARTXIDE² TRIO

    MDR report key: 18038642 · Received October 31, 2023

    Report

    Report Number
    3001431138-2023-00009
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 31, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08034108510903
    PMA / PMN Number
    K181867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE THE MANUFACTURER OF THE DEVICE PERFORMED OUR OWN INVESTIGATION BY GATHERING INFORMATION FORM THE CLINIC AND PERFORMING THE EVALUATION OF THE ACTUAL MEDICAL DEVICE INVOVLED IN THE EVENT. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN CHECKED IN DATE (B)(4) 2023 AND FOUND CORRECTLY WORKING WITHIN SPECIFICATIONS (SERVICE REPORT CASE ID#(B)(4)). THE ACTUAL BROKE FIBER HAVE NOT BEEN FOUND SO THE LOT OF IT HAVE NOT BEEN RETRIEVED (NOT AVAILABLE FOR ANY FURTHER ANLYSIS). THE FIBER USED IS SOLD BY DEKA M.E.L.A SRL AS ACCESSORY OF THE LASER BUT MANUFACTURED BY QUANTA SYSTEM SPA (MANUFACTURER PART NUMBER: HAF005003). THE FIBER IS ITSELF A MEDICAL DEVICE CE MARKED. SUCH ACCESSORY IS NOT MARKETED IN THE US TERRITORIES. SMARTXIDE2 TRIO SOLD IN THE US ARE EQUIPPED WITH A DIFFERENT FIBER MANUFACTURED BY LASER ENGINEERING AND CLEARED BY FDA WITH 510(K) K112166 . MOREOVER THE TECHNICIAN THAT WAS ON-SITE FOR THE DEVICE EVALUATION REPORTED THAT THE FIBER (WHICH IS A REUSABLE STERILE FIBER) IS NOT STERILIZED IN THE DEPARTMENT WHERE THE LASER IS IN USE BUT IN A DEDICATED DEPARTMENT OF THE HOSPITAL. THE PERSONNEL INTERVIEWED DID NOT KNOW HOW THE FIBER IS STERILIZED. THE PROCEDURE FOR STERILIZATION OF THE FIBER IS IDENTIFIED ON THE FIBER'S OPERATOR'S MANUAL THAT COMES WITH EACH FIBER (CODE DGM001425.01) AT CHAPTER "REPROCESSING". BASED ON THE FACT THAT THE BROKEN FIBER HAS NOT BEEN RETREIVED (LOT OF THE INVOVLED FIBER ALSO NOT AVAILABLE) IT IS NOT POSSIBLE TO FURTHER INVESTIGATE ON THIS ISSUE AND DETERMINE THE ROOT CAUSE OF THE EVENT. BASED ON THE FACT THAT THE ACTUAL FIBER WAS NOT RETREIVED AND THAT NO INFORMATION RELATIVE TO THE LOT HAS BEEN POSSIBILE TO BE GATHERED, IT IS IMPOSSIBLE TO FURTHER INVESTIGATE ON THIS ISSUE. IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE AND CONCLUSION RELATIVE TO THE BREAKAGE OF THE FIBER. THE RISK MANAGEMENT FILE OF THE DEVICE CODE RMF_M103XX_01 HAS BEEN EVALUATED FOR THE RISK RELATIVE TO UNWANTED LASER RADIATION DUE TO FIBER BREAKAGE AND FOUND ALIGNED FOR WHAT CONCERNS THE PROBABILITY OF THE EVENT POST-MITIGATION, IN THE LIGHT OF THE PRESENT EVENT. THE HARM LEVEL POST-MITIGATION HAS BEEN ALSO EVALUATED AND FOUND STILL ADEQUATE. THE RISK MANAGEMENT FILE HAS BEEN E FOUND STILL ADEQUATE WITHOUT ANY MODIFICATION TO THE SINGLE RISK AND OVERALL RISK-BENEFIT RATIO OF THE DEVICE. A REMEDIAL ACTION HAS BEEN PERFORMED IN DATE (B)(4), 2023 WITH THE EVALUATION OF THE DEVICE THAT HAS BEEN FOUND WORKING PROPERLY WITHIN SPECIFICATOINS. NO OTHER CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA IS REQUIRED. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON OCTOBER THE17TH, 2023, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF A MALFUNCTION, FFROM OUR TECHNICIAN BIAGIOLI, THAT PERFORMED A SERVICE INTERVENTION ON THE SMARTXIDE2 TRIO, INSTALLED AT AUSL IN BOLOGNA, AFTER THE BREAKAGE OF THE HOLLOW FIBER. WHILE THERE HE GOT INFORMED THAT THE BREAKAGE OF THE FIBER CAUSED THE BURNING OF A PHYSICIAN'S COAT AND A COVER SHEET DURING THE USE. THE ACTUAL DEVICE INVOLVED IS A MEDICAL DEVICE SMARTXIDE2 TRIO WHICH IS MARKETED IN THE US TERRITORIES WITH 510(K) K181867. FOLLOWING THE INITIAL INFORMATION SHARED WITH THE TECHNICIAN HE PROCEEDED TO GATHER MORE DETAILED INFORMATION ABOUT THE EVENT. THE PERSONNEL INTERVIEWED RESPONDED THAT THE HOSPITAL ALREADY PLACED A DEDICATED REPORT ON THE ITALIAN MOH FOR MEDICAL DEVICE VIGILANCE (DISPOVIGILANCE). SUCH REPORT, PROTOCOL 93909 HAS BEEN SHARED WITH AQ IN ORDER TO GIVE ALL THE INFORMATION AVAILABLE ABOUT THE EVENT. IN SUCH REPORT IT IS REPORTED THAT THE EVENT TOOK PLACE IN DATE 02/10/2023 AND THAT DURING THE USE OF THE DEVICE THE LASER FIBER GOT ON FIRE. SUCH FLAMES HAVE INTERESTED THE PHYSICIAN'S COAT AND THE STERILE FIELD, BOTH OF THEM FIREPROOF. THE FIBER, CONSEQUENTLY BROKE. IMMEDIATELY AFTER THE LASE HAS BEEN MOVE AWAY, THE STERILE FIELD RECONSTRUCTED AND THE INTERVENTION CONCLUDED WITHOUT THE USE OF THE LASER. IN SUCH REPORT IT IS REPORTED THAT NOR PATIENT OR OPERATOR GOT ANY CONSEQUENCE FROM THE EVENT. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON OCTOBER THE 17TH, 2023 BY SPECIFIC COMMUNICATION OF THE SERVICE TECHNICIAN AND CLINIC, AND EVALUATED THE EVENT REPORTABLE A,CCORDING TO FDA 21 CFR PART 1000-1040, BECAUSE THIS EVENT REPRESENTS AN ARO (UNWANTED LASER EMISSION) AND IS A REPORTABLE EVENT. THAT SAID, ACCORDING TO FDA 21 CFR PART 1003.10(C) IF THE MANUFACTURER IS REQUIRED TO REPORT TO THE FOOD AND DRUG ADMINISTRATION UNDER PART 803 OF THIS CHAPTER, THE MANUFACTURER SHALL REPORT IN ACCORDANCE WITH PART 803.THE ACTUAL DEVICE INVOLVED IS A MEDICAL DEVICE SMARTXIDE2 TRIO WHICH IS MARKETED IN THE US TERRITORIES WITH 510(K) K181867.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124918 DEKA SMARTXIDE² TRIO DEKA SMARTXIDE² TRIO GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103AJ1 08034108510903

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown