BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CLINIC

    MDR report key: 4962036 · Received July 31, 2015

    Report

    Report Number
    3001431138-2015-00001
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 30, 2015
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    PMA / PMN Number
    K031440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EL.EN SERVICE PERSONNEL CHECKED THE FAULTY UNIT AT CUSTOMER SITE. THE SHUTTER FLAG (DEFLECTING THE LASER BEAM FOR POWER CALIBRATION) WAS FOUND NOT ALIGNED AND IT DID NOT FULLY COVER THE LASER BEAM WHEN CLOSED. AN UNEXPECTED LASER EMISSION FROM LASER APERTURE OCCURRED. THE INSTRUMENTAL MEASUREMENT OF UNEXPECTED RADIATION CONFIRMED THAT IT IS MINOR. FAULTY UNIT HAS BEEN REPAIRED BY PERFORMING ALIGNMENT ADJUSTMENT OF SHUTTER FLAG. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY WAS RESPONSIBLE FOR CAUSING THE SHUTTER BREAKING DURING ITS USE. RATHER, IT COULD BE ASSUMED THAT THERE WAS A DAMAGE OF THE SHUTTER COMPONENT FOLLOWING A SUDDEN VIOLENT MECHANICAL SHOCK SUFFERED BY THE WHOLE LASER SYSTEM. CUSTOMER REFERS THAT THE DEVICE HAS DROPPED ON THE GROUND DURING HANDLING IN OPERATING ROOM SEVERAL MONTHS BEFORE. THE RISK OF SERIOUS INJURY IN CASE THIS EVENT WERE TO RECUR IS VERY LOW BECAUSE, SPECIFICALLY FOR THE RISK ON EYES, PROTECTIVE EYEWEAR ARE RECOMMENDED TO BE ALWAYS USED IN OPERATION ROOM BOTH FOR OPERATOR AN PT. PROBLEM LIMITED TO THIS UNIT ONLY. NO UNITS PLACED ON US MARKET OF THIS MODEL OR SIMILAR. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED A MALFUNCTION TO US, THAT OCCURRED DURING A MAINTENANCE FUNCTIONAL TEST ON THE MEDICAL DEVICE MODEL "SMARTCLINIC" CODE M059C2(230V-50/60HZ), MANUFACTURED BY EL. EN. ELECTRONIC ENGINEERING (B)(4). DURING THE FUNCTIONAL TEST, THE HEALTH PROFESSIONAL FOUND OUT THAT, DURING THE START-UP OF THE DEVICE, A MINOR UNEXPECTED LASER RADIATION COMES OUT FROM THE LASER APERTURE. WE, THE MR OF THE DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2015 BY EMAIL FROM THE CLINICAL ENGINEERING DEPARTMENT OF (B)(6). INITIAL REPORTER REQUESTED INTERVENTION OF EL.EN. SERVICE TO CHECK AND REPAIR THE DEVICE. WE, THE MFR, ADVISE THE OPERATOR TO NOT USE THIS DEVICE UNTIL EL.EN. SERVICE'S PERSONNEL EVALUATE THE DEVICE. EL.EN. SERVICE PERSONNEL EVALUATED THE ACTUAL DEVICE AT CUSTOMER SITE ON (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498922 SMART CLINIC POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA M072E2

    Patients

    Seq Age Sex Outcome Treatment
    1