BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4

    MDR report key: 3905097 · Received May 23, 2014

    Report

    Report Number
    3001431138-2014-00002
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 22, 2014
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K131095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOCAL DEKA SERVICE PERSONNEL CHECKED THE FAULTY UNIT AT CUSTOMER SITE. THE "SHUTTER FLAG" (DEFLECTING THE LASER BEAM FOR POWER CALIBRATION) WAS FOUND BROKEN. BROKEN SHUTTER (MECHANICAL COMPONENT) DETERMINED THE FAILURE OF CALIBRATION TEST (AUTOMATICALLY PERFORMED BY THE SYSTEM BEFORE TREATMENT START) AND AN UNEXPECTED SHORT TERM LASER EMISSION FROM HANDPIECE. NO SIMILAR FAULT REPORTED BEFORE FROM THE FIELD AGAINST MORE THAN ONE HUNDRED UNITS PLACED ON THE MARKET. FAULTY UNIT HAS BEEN REPAIRED BY REPLACING THE BROKEN COMPONENT AT CUSTOMER SITE BY LOCAL DEKA SERVICE. BROKEN COMPONENT WAS NOT RETURNED TO MANUFACTURE FACILITY BUT CLEARLY SHOWN ON A PICTURE. NO INJURIES REPORTED FOR PATIENT AND/OR OPERATOR. THE RISK OF SERIOUS INJURY IN CASE THIS EVENT WERE TO RECUR IS VERY LOW BECAUSE THE UNEXPECTED LASER EMISSION IS LIMITED FOR A SHORT TIME (UP TO CALIBRATION ERROR STATUS DETECTION AND SYSTEM ALARM ACTIVATION) AND BECAUSE, SPECIFICALLY FOR THE RISK ON EYES, PROTECTIVE EYEWEAR ARE RECOMMENDED TO BE ALWAYS USED IN OPERATION ROOM BOTH FOR OPERATOR AND PATIENT. THIS INITIAL REPORT IS SUBMITTED WITHIN DUE DATE (30 CALENDAR DAYS FROM MANUFACTURER AWARENESS DATE). A FOLLOW-UP OR FINAL REPORT WILL BE SUBMITTED ONCE AN OVERALL TECHNICAL EVALUATION IS COMPLETED BY MANUFACTURER. NOTE: FOLLOWING (B)(4) SYSTEM, A REPORT ABOUT THIS EVENT IS GOING TO BE SENT ALSO TO (B)(4).

    Description of Event or Problem · 1

    A FOREIGN DISTRIBUTOR REPORTED TO US ABOUT A CUSTOMER THAT HAD A MEDICAL LASER DEVICE MODEL "SYNCHRO REPLA:Y EXCELLIUM 3.4" (MANUFACTURED BY (B)(4)) WHICH FAILED INITIAL CALIBRATION TEST SHOWING THE "INT TEST ENERGY ERROR" STATUS ALARM MESSAGE. DURING THIS CALIBRATION PHASE, THE DEVICE EMITTED UNEXPECTED LASER RADIATION FROM THE HANDPIECE. EVENT OCCURRED AT DR. (B)(6). NO REPORTED INJURIES TO PATIENTS, OPERATORS OR ANY OTHER PERSONS PRESENT IN THE LASER OPERATING ROOM. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON (B)(4) 2014 BY EMAIL FROM THE (B)(4) LOCAL DISTRIBUTOR, (B)(4) SERVICE DEPARTMENT. THE ACTUAL DATE OF EVENT IS UNKNOWN BUT THE BEST ESTIMATE IS (B)(6) 2014. INVOLVED DEVICE IS SIMILAR TO DEVICE MODEL "SYNCHRO REPLAY EXCELLIUM/PREMIUM" MANUFACTURED BY THE COMPANY AND MARKETED IN USA TERRITORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309095 DEKA SYNCHRO REPLA:Y EXCELLIUM 3.4 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M104H1

    Patients

    Seq Age Sex Outcome Treatment
    1