BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA MOTUS AX

    MDR report key: 8004968 · Received October 25, 2018

    Report

    Report Number
    3001431138-2018-00007
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    September 20, 2018
    Report Date
    November 14, 2018
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K162886
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ACTUAL DEVICE INVOLVED IN THE ADVERSE EVENT HAS BEEN EVALUATED BY MANUFACTURER'S SERVICE TECHNICIAN AT CUSTOMER SITE IN DATE OCTOBER THE 29TH, 2018 AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS PRIOR TO ANY SERVICE INTERVENTION (SERVICE REPORT #(B)(4)). THE TECHNICIAN, FOLLOWING THE EVALUATION OF THE DEVICE PROCEEDED TO PERFORM THE ROUTINARY MAINTENANCE OF THE DEVICE. THE PHYSICIAN DR. (B)(6) WAS PRESENT DURING THE WHOLE TIME OF THE SERVICE EVALUATION OF THE DEVICE AND RESPONDED TO THE QUESTION ASKED BY THE TECHNICAL AND RELATIVE TO THE INVESTIGATION OF THIS CASE OF ADVERSE EVENT. THE TECHNICIAN ASKED ABOUT THE PROCEDURE PERFORMED BY THE PHYSICIAN AND HE CONFIRMED WHAT STATED IN THE PREVIOUS COMMUNICATION (ALREADY REPORTED IN THE INITIAL REPORT) REGARDING THE SETTINGS OF THE DEVICE FOR THE TREATMENT AND THE FACT THAT HE HAVE NOT PERFORMED A SKIN TEST PREVIOUS THE TREATMENT. MOREOVER HE STATED THAT HE WAS NOT AWARE THAT SCARS (CLASSIFIABLE AS A SKIN DISORDER) ARE CONTRAINDICATED FOR THE TREATMENT. HE ALSO DECLARED THAT THE PATIENT WAS AT HER VERY FIRST TREATMENT WITH HIM. THE PHYSICIAN ALSO STATED THAT THIS PATIENT WAS HIS VERY FIRST TREATMENT ON SKIN TYPE VI (FITZPATRICK SCALE). INFORMATION RELATED TO THE CONTRAINDICATED AREAS ARE CLEARLY DEFINED IN THE OPERATOR'S MANUAL CODE OM112A_G.V06 AT CHAPTER 11.1 'CONTRAINDICATION' WHERE IS STATED AS A CAUTION - POSSIBLE RISK FOR PATIENT/OPERATOR "DO NOT PERFORM THE TREATMENT ON TATTOO OR SKIN DISORDERS". MOREOVER THE OPERATOR'S MANUAL REPORTS AT CHAPTER 11.3 'TREATMENT RECOMMENDATIONS' TO PERFORM THE SKIN TEST "[...]BEFORE STARTING THE TREATMENT TO DETERMINE THE CORRECT VALUES FOR THE TREATMENT PARAMETERS AVAILABLE (FLUENCE AND PULSE TYPE) WHICH SUITS THE TYPE OF SKIN OF THE PATIENT, SO THAT THE USER CAN BE REASONABLY SURE THAT THE TREATMENT WILL NOT DAMAGE THE SKIN. A SKIN TEST MUST BE PERFORMED IN THE FOLLOWING CASES: AT THE FIRST TREATMENT FOR A NEW SUBJECT NEVER TREATED BEFORE [...]". THAT SAID IS CLEAR THAT CRITICAL PRECAUTION WERE NOT TAKEN BY THE PHYSICIAN BEFORE AND DURING THE TREATMENT IN CONTRADICTION WITH WHAT STATED IN THE INSTRUCTION FOR USE. IN FACT HE DID NOT PERFORM THE SKIN TEST, THAT COULD HAVE COMPLETELY AVOIDED THE ADVERSE EVENT, AND TREATED THE PATIENT ON AN EVIDENT SCAR. THIS ASPECTS IN CONJUNCTION WITH THE INEXPERIENCE OF THE PHYSICIAN WITH THIS SKIN TYPE (DARK SKIN) LED TO THE ADVERSE EVENT. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY OR DEVICE MALFUNCTIONING WAS RESPONSIBLE FOR CAUSING THE EVENT. RATHER, IT IS POSSIBLE TO CONCLUDE, BASED ON THE ABOVE MENTIONED INVESTIGATION, THAT THERE WAS A HUMAN FACTORS ISSUE, WHERE A FAILURE TO PERFORM THE PROPER EVALUATION TO DETERMINE THE CORRECT PARAMETER TO SUIT THE PATIENT'S CONDITION AND PERFORM THE TREATMENT ON A CONTRAINDICATED AREA, CONTRIBUTED TO THE EVENT. BY MANUFACTURER'S INVESTIGATION THE OPERATOR'S MANUAL AND RISK ANALYSIS ARE ADEQUATE. DEVICE WORKING WITHIN SPECIFICATIONS. NO REMEDIAL ACTION REQUIRED. THIS FOLLOW-UP REPORT HAS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PHYSICIAN WAS UNRESPONSIVE UNTIL OCTOBER THE 19TH, 2018 AND THE TECHNICAL EVALUATION OF THE DEVICE WAS NOT POSSIBLE. AT THE TIME OF THE PRESENT REPORT THE MANUFACTURER'S SERVICE DEPARTMENT IS SCHEDULING A SPECIFIC TRIP TO PERFORM THE EVALUATION OF THE DEVICE AND GATHER MORE DETAILED INFORMATION FROM THE PHYSICIAN. THAT SAID, BASED ON THE INFORMATION REPORTED BY THE PHYSICIAN, IS NOT YET POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT EVEN IF A USER ERROR IS SUSPECTED. IN FACT, THE PHYSICIAN DID NOT REPORTS IF MORE PASSAGE HAS BEEN DONE ON THE SAME AREA WHICH IS A CRUCIAL INFORMATION IN ORDER TO UNDERSTAND THE ACTUAL AMOUNT OF ENERGY DELIVERED IN A SPECIFIC AREA. ANYWAY IS CLEAR THAT THE TREATMENT WAS PERFORMED IN A CONTRAINDICATED AREA, AS DEFINED IN THE OPERATOR'S MANUAL CODE OM112A1_G.V06 AT CHAPTER 11.1 'CONTRAINDICATIONS', BECAUSE AN EVIDENT SCAR IS PRESENT. MOREOVER THE PHYSICIAN ALSO STATED THAT HE DID NOT PERFORM THE REQUIRED SKIN TEST AS INDICATED IN THE OPERATOR'S MANUAL AT CHAPTER 11.4 'TREATMENT RECOMENDATIONS' THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN EVALUATED YET BUT A SPECIFIC SERVICE TRIP IS GOING TO BE ARRANGED IN ORDER TO DETERMINE IF THE DEVICE IS WORKING PROPERLY WITHIN SPECIFICATIONS. INVESTIGATION STILL ON GOING. NO ROOT CAUSE DETERMINED AND NO REMEDIAL ACTION DEFINED. THIS REPORT HAS TO BE CONSIDERED AS AN INITIAL REPORT. A SPECIFIC FOLLOW UP TO THIS MDR WILL BE SUBMITTED IN A TIMELY MANNER AS SOON AS NEW INFORMATION WILL BE GATHERED.

    Description of Event or Problem · 1

    IN DATE SEPTEMBER THE 27TH 2018, MR (B)(4) OF (B)(4) DISTRIBUTOR SENT A COMMUNICATION TO EL.EN., RELATIVE TO AN ADVERSE EVENT IN WHICH THE PATIENT REPORTED BURNS AND BLISTERING IN THE BIKINI AREA FOLLOWING A HAIR REMOVAL TREATMENT WITH THE MOTUS AX LASER MEDICAL DEVICE (REF: M112A1 - S/N: (B)(4)). THIS MODEL IS NOT MARKETED IN THE USA BUT A SIMILAR DEVICE, REF M112B1 IS SOLD IN THE USA WITH 510(K) NUMBER K162886. THE COMMUNICATION REPORTED, MOREOVER, THAT THE PATIENT WAS A SKIN TYPE 6 (FITZPATRICK SCALE) AND WAS SUPPORTED WITH IMAGES OF THE TREATED AREA. BY THE IMAGES IS EVIDENT THAT THE AREA TREATED COVERED ALSO AN EVIDENT SCAR. BOTH THE DISTRIBUTOR AND US, AS THE MANUFACTURER OF THE DEVICE, HAVE TRIED TO REACH THE PHYSICIAN IN ORDER TO HAVE MORE DETAILED INFORMATION REGARDING THE TREATMENT AND THE ACTUAL STATE OF HEALTH OF THE PATIENT. THE PHYSICIAN WAS UNRESPONSIVE FOR A LONG TIME. WE RECEIVE INFORMATION FROM HIM IN DATE (B)(6) 2018 BUT THE DETAILS REPORTED RELATIVE TO THE TREATMENT PARAMETER, PROCEDURE, STATE OF HEALTH OF THE PATIENT ARE NOT VERY DETAILED. THE INFORMATION REPORTED STATED THAT THE EVENT TOOK PLACE IN DATE (B)(6) 2018 WITH THE FOLLOWING PARAMETERS: FLUENCE=4J/CM2-SOFT, TOTAL ENERGY DELIVERED TO THE PATIENT= 2000J, REPETITION RATE=3HZ, NUMBER OF PASSAGES ON THE SAME SPOT= UNKNOWN, SKIN TEST: NOT PERFORMED. THE PATIENT WAS TREATED, FOLLOWING THE EVENT, WITH DEXERYL AND REFROIDIR. THIS CASE HAS BEEN EVALUATED AS REPORTABLE BECAUSE THE LESION REPORTED BY THE PATIENT CAN BE CONSIDERED AS A SERIOUS INJURY (ON THE SIDE OF CAUTION BASED ONLY ON THE IMAGES PROVIDED INITIALLY) AND BECAUSE THE PATIENT RECEIVED MEDIAL ATTENTION FOLLOWING THE EVENT. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON SEPTEMBER THE 27TH, 2018 BY EMAIL FROM THE (B)(4) DISTRIBUTOR AND, ACCORDING TO 21 CFR PART 803, SUBMITTED TO FDA AN OWN MDR..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847575 DEKA MOTUS AX DEKA MOTUS AX GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M112A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R