BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTXIDE 50 HS

    MDR report key: 18028147 · Received October 30, 2023

    Report

    Report Number
    3001431138-2023-00008
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 30, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K101904
    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 THIS EVENT HAS BEEN MANUFACTURED ON NOVEMBER 2011 AND UNDERWENT ORDINARY MAINTENANCE ONLY TWO TIMES (IN 2017 AND 2023). IN ORDER TO GUARANTEE THE CORRECT OPERATIVITY OF THE DEVICE WE, THE MANUFACTURER OF THE DEVICE, ADVICE THE OPERATORS TO PERFORM ORDINARY MAINTENANCE ONECE A YEAR (AS PER INDICATION REPORTED ON THE OPERATOR'S MANUAL CODE OM079W1_I.V03 - ACTUAL REVISION SHIPPED WITH THE DEVICE - AT CHAPTER 'MAINTENANCE'). IMMEDIATELY AFTER THE COMMUNICATION OUR SERVICE DEPARTEMENT IMMEDIATELY CONTACTED THE SITE IN ORDER TO BOOK AN APPOINTMENT TO CHECK THE DEVICE. THE EVALUATION OF THE DEVICE HAS BEEN PERFORMED IN DATE (B)(6) 2023 BY DEKA SERVICE PERSONNEL (SERVICE REPORT CASE ID#(B)(4). THE DEVICE HAS BEEN POWERED ON AND IMMEDIATELY CHECKED THE OUTPUT'S ENERGY THAT HAS BEEN FOUND WELL WITHIN SPECIFICATIONS. AFTER ABOUT 15 MINUTES THE DEVICE PRESENTED THE FLOW ALARM. TECHNICIAN THAN PROCEEDED TO INSPECT THE DEVICE AND FOUND THE CAUSE OF THE ISSUE TO BE THE FLUID COOLANT PUMP. THIS COMPONENT HAS BEEN REPLACED AND THE DEVICE, THEN, CALIBRATED AND AGAIN CHECKED TO BE LEFT WITHIN SPECIFICATIONS. THE FLUID COOLANT PUMP HAS NEVER BEEN REPLACED BEFORE ON THIS DEVICE. DUE TO THE FACT THAT THE DEVICE IS ALMOST 13 YEARS OLD (WHILE THE MANUFACTURER'S EXPECTED SERVICE LIFE IS SET TO 5 YEARS) THE FAULT OF THE COOLING LIQUID PUMP CAN BE ASSUMED AS A NORMAL WEAR OF THE MECHANICAL COMPONENT (AGEING OF THE COMPONENT). NO DESIGN DEFICENCY HAS BEEN FOUND TO BE THE CAUSE OR CONTRIBUTED TO THE EVENT. THE EVALUATION OF THE EVENT HAS NOT FOUND ANY EVIDENCE OF EVENTUAL TREND ON COOLANT PUMP FAULTS THAT CAN JUSTIFY AN INCREASE IN PROBABILITY OF THE EVENT ON OTHER SIMILAR DEVICES. THIS EVENT IS AN ISOLATED CASE CAUSED SOLELY BY THE FORESEEABLE AGING OF A COMPONENT (COOLANT FLUID PUMP) FOLLOWING SEVERAL YEARS OF SERVICE. THE RISK MANAGEMENT FILE OF THE DEVICE CODE RMF_M079XX1_02 HAS BEEN EVALUATED FOR THE RISK RELATIVE TO FAULT OF THE DEVICE DUE TO COMPONENT'S AGEING. IN THE LIGHT OF THE PRESENT EVENT THE RISK HARM LEVEL AND HARM FREQUENCY, POST-MITIGATION, HAS BEEN FOUND STILL ADEQUATE. BASED ON THAT THE RISK MANAGEMENT FILE HAS BEEN EVALUATED ADEQUATE WITHOUT THE NEED OF ANY UPDATE. A REMEDIAL ACTION HAS BEEN PERFORMED IN DATE (B)(6) 2023: REPAIR OF THE DEVICE WITH REPLACEMENT OF THE COOLANT FLUID PUMP. NO OTHER CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA IS REQUIRED: NO DESIGN DEFICENCY IDENTIFIED AS ROOT CAUSE OF THE EVENT. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, (B)(6). ELECTRONIC ENGINEERING SPA BECAME AWARE OF A MALFUNCTION, FROM THE ITALIAN SALES AGENT FOR SOUTHERN ITALY, RELATIVE TO A MALFUNCTION WITH THE DEVICE SMARTXIDE 50 HS, INSTALLED AT CASA DI CURA VILLA MARIA (ITALY), THAT PRESENTED A FLOW ALARM DURING A SURGERY INTERVENTION ON A PATIENT CAUSING THE STOP OF THE SURGERY. THE SURGERY WAS INTENDED FOR THE REMOVAL OF A CARCINOMA IN THE THROAT. THE NARRATIVE PROVIDED BY THE PHYSICIAN REPORTED THAT THE EVENT TOOK PLACE DURING THE SURGERY AND REQUIRED THE PHYSICIAN TO CONCLUDE THE SURGERY WITH AN ALTERNATIVE METHOD (ELECTROSURGICAL BLADE). THIS CAUSED TO THE PATIENT A LONGER TIME FOR HEALING POST-SURGERY DUE TO EDEMA AND DYSPHAGIA. THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT IS A SMARTXIDE 50 HS WITIH REF: (B)(4)MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K101904. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN MANUFACTURED ON NOVEMBER 2010 AND UNDERWENT ORDINARY MAINTENANCE ONLY TWO TIMES (IN 2017 AND 2023). IN ORDER TO GUARANTEE THE CORRECT OPERATIVITY OF THE DEVICE WE, THE MANUFACTURER OF THE DEVICE, ADVICE THE OPERATORS TO PERFORM ORDINARY MAINTENANCE ONCE A YEAR (AS PER INDICATION REPORTED ON THE OPERATOR'S MANUAL CODE OM079W1_I.V03 - ACTUAL REVISION SHIPPED WITH THE DEVICE - AT CHAPTER 'MAINTENANCE'). WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2023 BY SPECIFIC COMMUNICATION OF THE ITALIAN SALES AGENT, AND EVALUATED THE EVENT REPORTABLE DUE TO THE FACT THAT THE PATIENT WAS ALREADY SEDATED, BECAUSE IT REPRESENTS AN INDIRECT HARM TO THE PATIENT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156163 SMARTXIDE 50 HS SMARTXIDE 50 HS GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M079W1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other