BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGMA SYSTEM

    MDR report key: 9746321 · Received February 24, 2020

    Report

    Report Number
    3011670002-2020-00001
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    May 22, 2016
    Report Date
    December 19, 2019
    Manufacturer
    FORMATEK SYSTEMS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO 21 CFR PART 807.87 [E] EACH MAGMA DEVICE SHALL BE ATTACHED WITH A USER MANUAL AND ANY OTHER INFORMATION. EACH MAGMA DEVICE IS PROVIDED TO THE DISTRIBUTOR ACCORDING TO THIS CFR. THE USER MANUAL STATES THAT THE MAGMA DEVICE SHALL BE USED IN ACCORDANCE WITH THE MAGMA DEVICE CLINICAL PROTOCOL [(B)(4)] BY MAGMA DEVICE OPERATORS. IN THIS CLINICAL PROTOCOL, FORMATEK SYSTEMS LTD IMPLEMENTED ITS CONCLUSIONS FROM ITS CLINICAL TESTS ACCORDING TO 21 CFR PART 807.92(B)(3) FOR THE MAGMA.. THE CONCLUSIONS ARE SUMMARISED IN A TABLE OF VALUES WHICH SHALL BE USED ACCORDING TO THE TREATED SKIN TYPE. THE VALUES IN THE TABLE REPRESENT BOTH PULSE MODES AND THE ENERGY LEVELS WHICH ARE CRITICAL IN SELECTING THE APPROPRIATE TREATMENT PARAMETERS. ACCORDING TO THE CLINICAL PROTOCOL [(B)(4)], PATIENTS WITH SKIN TYPE V (5) SHALL BE TREATED BY USING A SPECIFICALLY DESIGNATED PULSE MODE NAMED MODE 100MS. THE CLINICAL PROTOCOL OUTLINES THE IMPORTANCE AND CLINICAL RATIONAL OF USING THIS PULSE MODE FOR TREATING PATIENTS WITH SKIN TYPE V (5) UNDER SECTION 3.4.4. IN SHORT, WHILE MODE SLOW UTILIZES A SINGLE PULSE TO DELIVER THE ENERGY, MODE 100MS UTILIZES MULTIPLE PULSES EMITTED OVER A LONGER PULSE DURATION IN ORDER TO ALLOW FOR SUFFICIENT ENERGIES TO BE DELIVERED IN A SAFE WAY FOR PATIENTS WITH SKIN TYPE V (5). AS A RESULT, WHILE EVEN IF THE ENERGY LEVELS CAN BE SIMILAR BETWEEN THE TWO MODES (SLOW / 100MS), THE INTERACTION OF THE LASER WITH A PATIENT'S SKIN IS VERY DIFFERENT. ADDITIONALLY, ACCORDING TO THE CLINICAL PROTOCOL [(B)(4)], THE APPROVED ENERGY LEVEL FOR PATIENTS WITH SKIN TYPE V (5) IS 16 [J/CM2]. THE FINDINGS OF OUR INVESTIGATION CONCLUDED THAT DURING THE (B)(6) 2016 (B)(6) TEAM [ THE SUBMITTER OF EMDR # MW5091783 ] USED THE MAGMA DEVICE IN NON-APPROVED MODE SLOW USING 18 [J/CM2] TO TREAT A PATIENT WITH SKIN TYPE V (5). THIS USE OF NON-APPROVED PULSE MODE AND NON-APPROVED ENERGY LEVELS IS AN OBVIOUS MISUSE OF THE DEVICE THAT LEAD TO THE SKIN BURNS REPORTED BY (B)(6) AS EMDR # MW5091783. THE MATERIALS USED IN OUR INVESTIGATION INCLUDED THE USE OF OUR DISTRIBUTOR IN THE (B)(4) QUALITY RECORDS AS WELL AS OFFICIAL DOCUMENTS SUBMITTED BY (B)(6) [ THE SUBMITTER OF EMDR # MW5091783] TO FORMATEK SYSTEMS AS WELL AS TO FORMATEK'S DISTRIBUTOR IN THE (B)(4). THE USE OF THE MAGMA NOT ACCORDING TO THE MANUFACTURER SPECIFIC INSTRUCTIONS IS DEFINED BY THE FDA AS DEVICE MISUSE ACCORDING TO 21 CFR PART 803.3(K). TO THE BEST OF OUR UNDERSTANDING OF OUR DEVICES, WHICH WE DESIGNED, THE TREATMENT PARAMETERS USED BY (B)(6) TEAM FOR SKIN TYPE V (5) WERE MADE WITHOUT PROPER CLINICAL INVESTIGATIONS AS EXPLICITLY REQUESTED ACCORDING TO 21 CFR PART 812. THIS EMDR # MW5091783 IS AN EVENT OF DEVICE MISUSE, AS THE COMPLAINER DID NOT USE THE DEFINED DEVICE SETTINGS, THE DEVICE WAS CLEARED BY THE FDA AFTER A VERY INFORMATIVE CLINICAL STUDY MADE ACCORDING TO THE REQUIREMENTS OF THE 21 CFR. (B)(4).

    Description of Event or Problem · 1

    THE EMDR COMPLAINT WAS ABOUT OUR LASER WHICH CAUSED "SERIOUS AND SIGNIFICANT BURNS TO THE BACK OF A PATIENT". "CLAIMS/WARRANTIES MADE BY THE DISTRIBUTER (AND THE SAME CLAIMS THAT ARE STILL BEING MADE BY THE MANUFACTURER WAS ABLE TO MITIGATE THE PERFORMANCE IMPACT OF THE BURNS TO THE PATIENT THROUGH AN EXTENSIVE COURSE OF SKIN TREATMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208058 MAGMA SYSTEM MAGMA SYSTEM GEX FORMATEK SYSTEMS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention