BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTOSILK PLUS

    MDR report key: 4337092 · Received December 5, 2014

    Report

    Report Number
    3001431138-2014-00003
    Event Type
    Injury
    Date Received
    December 5, 2014
    Date of Event
    November 5, 2014
    Report Date
    December 5, 2014
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A
    Product Code
    GEX
    PMA / PMN Number
    K041095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOCAL EL.EN SERVICE PERSONNEL CHECKED THE FAULTY UNIT AT CUSTOMER SITE. THE PULSED LIGHT HANDPIECE WAS FOUND WITH EXTERNAL LIGHT FILTER GLASS AND INTERNAL FLASH LAMP BROKEN. THE PHOTOSILK PLUS UNIT HAD BEEN REPAIRED AT CUSTOMER SITE BY REPLACING THE BROKEN HANDPIECE WITH A NEW ONE BY LOCAL EL.EN SERVICE. BROKEN HANDPIECE HAS BEEN RETURNED AT CUSTOMER MANUFACTURE FACILITY, BUT IT IS CORRECTLY WORKING. THE RISK OF SERIOUS INJURY IN CASE THIS EVENT WERE TO RECUR IS VERY LOW BECAUSE, SPECIFICALLY FOR THE RISK ON EYES, PROTECTIVE EYEWEAR IS RECOMMENDED IN THE INSTRUCTION FOR USE, TO BE ALWAYS USED IN OPERATION ROOM BOTH FOR OPERATOR AND PT DURING TREATMENTS. THIS INITIAL REPORT IS SUBMITTED WITHIN DUE DATE (30 CALENDAR DAYS FROM MANUFACTURER AWARENESS DATE). A FOLLOW-UP OF FINAL REPORT WILL BE SUBMITTED ONCE AN OVERALL TECHNICAL EVAL IS COMPLETED BY MANUFACTURER ON THE ACTUAL SUSPECT DEVICE. NOTE: FOLLOWING (B)(4) VIGILANCE SYSTEM (MEDDEV 2.12-1 REV 8), A REPORT ABOUT THIS EVENT HAS BEEN ALSO SENT TO (B)(4) COMPETENT AUTHORITY (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED AN ADVERSE EVENT TO US, THAT OCCURRED DURING A PULSED LIGHT TREATMENT ON A FEMALE PT WITH A MEDICAL DEVICE MODEL "PHOTOSILK PLUS" CODE M072E2 (230V-50/60HZ), MANUFACTURED BY EL.EN.ELECTRONIC ENGINEERING (B)(4). DURING TREATMENT FOR SKIN DISCOLORATION, THE PULSED LIGHT HANDPIECE, HAND-HELD BY THE DOCTOR, WAS SUDDENLY BROKEN WITH LEAKING WATER. A PIECE OF GLASS OF LIGHT FILTER HIT THE PT'S FACE CAUSING A SMALL CUT (ABOUT ONE CM) ON HER LEFT CHEEKBONE. PT'S EYES WERE PROTECTED BY SAFETY GOGGLES REQUIRED FOR TREATMENT. THE NEXT DAY (B)(6) 2014, THE PT WENT TO A LOCAL HOSP FOR A VOLUNTARY MEDICAL EXAMINATION AND RX. PT INFORMED PHYSICIAN BY LETTER. WE, THE MFR OF THE DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2014 BY EMAIL FROM THE PHYSICIAN TO EL.EN (B)(4) DOMESTIC SALES LOCAL AGENT. THE EVENT OCCURRED AT "(B)(6). THE INVOLVED DEVICE IS SIMILAR TO DEVICE MODEL "PHOTOSILK PLUS" CODE M072L1/M072T1 (115V-60HZ VERSION), MANUFACTURED BY THE COMPANY AND MARKETED IN US TERRITORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786200 PHOTOSILK PLUS INTENSE PULSE LIGHT SYSTEM GEX EL.EN. ELECTRONIC ENGINEERING S.P.A M072E2

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other